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Results for “Glycemic variability”

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PubMed1995

Hormonal contraception in women with IDDM. Influence on glycometabolic control and lipoprotein metabolism.

OBJECTIVE: Safe and effective contraceptive methods are essential for women with insulin-dependent diabetes mellitus (IDDM), but opinions on the use of hormonal oral contraceptives by these women are conflicting. We evaluated the effects on glycometabolic control and lipoprotein metabolism in women with IDDM treated with an oral contraceptive not previously studied in a diabetic population. RESEARCH DESIGN AND METHODS: A total of 22 women with IDDM received a monophasic combination of ethinyl estradiol and gestodene for 1 year; 20 women of comparable diabetic status using nonhormonal contraception were selected as control subjects. Evaluation was performed before and after 1, 3, 6, and 12 months of hormonal intake using nonparametric statistical methods. RESULTS: Except for a higher median age of the control group, the baseline values for all clinical and metabolic variables were similar in the two groups, and in neither of the groups were changes in blood pressure, body mass index, or glycemic control observed. In the oral contraceptive group, decreased serum levels of low-density lipoprotein (LDL) cholesterol and increased levels of triglycerides and lipoprotein A were noted, whereas total cholesterol and high-density lipoprotein cholesterol levels were unchanged. In the control group, a decrease of LDL cholesterol was observed. No effect of tobacco smoking on glycometabolic control or lipoprotein metabolism could be demonstrated during hormonal intake. CONCLUSIONS: No evidence of impaired glycometabolic control or adverse changes in serum levels of lipoproteins known to be associated with atherosclerosis was observed in women with well-controlled IDDM during 1 year of oral contraception with ethinyl estradiol and gestodene.

Adult↗

PubMedDate not supplied

Clinical predictors of mucormycosis in children with type 1 diabetes mellitus.

BACKGROUND: Mucormycosis is an acute, often rapidly fatal fungal infection that is an important cause of death in young patients with diabetes mellitus (DM) who have poor glycemic control and acute ketosis. Despite the importance of this condition, the clinical predictors of mucor infection are not well defined. METHODS: A retrospective chart review was carried out for five patients, age 14-19 years, diagnosed with mucormycosis at the University of Florida between 1984 and 1999. For the three patients for whom adequate information was available, two randomly selected, age-matched case controls were selected and compared to affected patients for the following variables: average HbA1c concentrations, number of missed clinic appointments, and the number of hospital and Diabetes Project Unit (DPU) admissions. RESULTS: HbA1c levels were similar in affected patients and controls, indicating glycemic control is not the principal factor predisposing to mucor infection. African-American race and poor compliance, as evidenced by poor clinic attendance, risk-taking behaviors and high admission rate to the DPU, were predictors of increased susceptibility to infection with mucormycosis.

Adolescent↗

PubMedDate not supplied

Risk factors associated with depression in patients with type 2 diabetes mellitus.

BACKGROUND: This study was undertaken in order to identify the prevalence and factors associated with depression in a group of patients with type 2 diabetes mellitus. METHODS: Our design consisted of a cross-sectional study at the Department of Neurology and Psychiatry of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City. Study units included 189 patients with type 2 diabetes mellitus (DM). Beck Depression Inventory scale was used to measure the presence of depression, while the independent variables evaluated to explain depression were sociodemographic (gender, marital status, religion, education, occupation, socioeconomic status) and characteristics of the disease were disease duration, comorbidity, compliance, and glycemic control. RESULTS: Prevalence of depression was 39% (74 patients). The following risk factors were identified by univariate analysis: being widowed (OR 3.54, confidence interval [CI] 1.56-8.11, p = 0.0007); female (OR 2.95, CI 1.50-5.82, p = 0.006); housewife (OR 2.08, CI 1.10-3.94, p = 0.01); poor compliance (OR 2.14, CI 1.12-4.10, p = 0.01), and presence of comorbidity (OR 5.60, CI 1.51-24.5, p = 0.002). On the other hand, the most constant associations were presence of blood glucose at the last appointment >or=200 (OR 3.23, CI 1.59-6.60, p = 0.0003) and >or=250 (OR 2.15, CI 0.93-5.03, p = 0.05), as the average of the last five blood glucoses >or=200 (OR 3.67, CI 1.76-7.73, p = 0.0001), >or=250 (OR 4.07, CI 1.61-10.49, p = 0.0007) and >or=300 (OR 2.12, CI 1.48-3.02, p = 0.003). Discriminant function analysis of the variables, previously studied in univariate analysis, was carried out for the presence of depression. A stepwise model included the following variables: average of the last five blood glucoses; 2) widowed or divorced, and 3) female. CONCLUSIONS: Frequency of depression in patients with type 2 DM was high (39%). High level of blood glucose stands out as a variable associated with presence of depression. Other associations were presence of comorbidity, being a female, and being widowed or divorced.

Aged↗

PubMed2002

The effect of high- and low-glycemic index energy restricted diets on plasma lipid and glucose profiles in type 2 diabetic subjects with varying glycemic control.

OBJECTIVE: To determine whether glycemic index (GI) differentially affects improved glucose and lipid profiles observed during weight loss in overweight subjects previously diagnosed with type 2 diabetes with variable glucose tolerance. METHODS: Twenty-three female and twenty-two male overweight subjects participated in 12 weeks of energy restriction (average BMI 33.2 kg/m2, age 56.7 years, glycated hemoglobin (GHb) 6.7%). After a four-week run-in on a high saturated fat (SFA) diet (1540 kcal/day, 17% SFA), the free-living subjects were randomly assigned to either a high- (75 GI units) or low- (43 GI units) GI diet (1440 kcal/day, 60% carbohydrate, 5% SFA) for eight weeks. Weight, serum lipids, plasma glucose and glycated hemoglobin were measured every four weeks. An oral glucose tolerance test (OGTT) was also performed at baseline, weeks 4 and 12. From the baseline OGTT results subjects were divided into three groups of low, median and high glucose tolerance. RESULTS: At baseline, BMI, age and glycated hemoglobin concentrations were not different between subjects allocated to the high- or low-GI diets. After four weeks, weight loss was 3.6+/-0.3 kg. Fasting glucose (-5.6%), glycated hemoglobin (-2.8%), area under the glucose curve (-13.0%) and triglyceride (-13.8%) concentrations were reduced (p < 0.02). Between weeks 4 and 12 reductions were observed in weight (-4.9%), fasting glucose (-4.6%), area under glucose curve (-10.1%), glycated hemoglobin (-7.2%), triglyceride (-7.5%) and LDL-C (-13.2%) concentrations. Weight loss was not different between low and high-GI diets. However, glycated hemoglobin was reduced twofold more in subjects consuming a low-GI diet as compared to subjects consuming a high-GI diet, but this was not statistically significant. LDL concentrations were also reduced more in subjects with low glucose tolerance on the low-GI diet (p = 0.02). CONCLUSION: Weight loss produces substantial improvements in glycemic control and lipoprotein metabolism. Lowering the glycemic index of high carbohydrate, low fat diets increases the fall in LDL cholesterol in subjects with type 2 diabetes with low glucose tolerance, but has little effect on glycemic control.

Blood Glucose↗

PubMed2006

A patient with severe, recurrent hypoglycemia and glycemic lability who underwent islet transplantation.

BACKGROUND: A 48-year-old woman who was diagnosed with type 1 diabetes at 5 years of age presented to our Clinical Islet Transplant Program with severe, recurrent hypoglycemia and glycemic lability. She was diligent with her diet, used a continuous subcutaneous insulin infusion pump (32 U per day), and monitored her glucose levels typically eight times a day. The patient usually had one hypoglycemic reaction a day, experienced a severe reaction once a month, and had marked variability of her glucose values. On presentation, her HYPO score was 584 and her lability index was 868 mmol/l(2)/h per week. INVESTIGATIONS: HYPO score, lability index score, screening for diabetes complications, and routine pretransplant evaluation. DIAGNOSIS: Severe, recurrent hypoglycemia and glycemic lability associated with type 1 diabetes. MANAGEMENT: The patient underwent islet transplantation. Post-transplant, the problems with hypoglycemia abated and excellent stable glycemic control was attained, although some side effects from the immunosuppressive drug, sirolimus, were evident. Insulin was reinstituted 2.5 years after surgery, at lower doses than before the transplant because of deterioration in graft function. Occasional episodes of hypoglycemia have occurred and some glycemic lability has recurred, although endogenous insulin secretion is still preserved.

Blood Glucose↗

PubMed2003

Glycemic, auxologic, and seasonal aspects of continuous subcutaneous insulin infusion therapy in children and young adults with type 1 diabetes.

Use of continuous subcutaneous insulin infusion (CSII) therapy has increased among patients with type 1 diabetes. This study was performed: (1) to evaluate the effect of CSII on diabetes control in children and young adults, (2) to detect effects of CSII on weight, body mass index (BMI), and insulin requirements, (3) to investigate seasonal variation in diabetes control during CSII therapy, and (4) to investigate the effect of season of initiation of CSII on glycemic control. Thirty-nine patients, ranging in age from 10.1 to 20.5 years, with type 1 diabetes were studied. Quarterly data over 12 months preceding and following CSII initiation were obtained retrospectively. Variables were compared over similar time periods. SAS was used for descriptive and paired t test analysis. (1) Mean blood glucose level was significantly lower at 3 months but not different from baseline at 6, 9, and 12 months post-CSII. (2) Glycosylated hemoglobin (HbA1c) was significantly lower at 3 and 6 months but not at 9 and 12 months post-CSII. (3) There was no significant difference in the frequency of hypoglycemia or hyperglycemia at any of the time periods studied. (4) There was an initial but unsustained decrease in daily weight-adjusted insulin requirements after CSII. (5) There was a rapid, sustained increase in weight and BMI following CSII in females. (6) Frequency of ketoacidosis decreased in two patients. (7) There was no seasonal variation in weight change, HbA1c, or frequency of measured hypoglycemic episodes with CSII. (8) There was some effect of the season of initiation of CSII therapy on glycemic control. Thus, (1) CSII glycemic benefits may not be sustained, (2) weight gain is a significant effect of CSII in adolescent females, and (3) CSII may be a means of decreasing ketoacidosis episodes, and eliminating seasonal variability in diabetes control.

Administration, Cutaneous↗

PubMed2001

Glycemic control is related to the morphological severity of diabetic sensorimotor polyneuropathy.

OBJECTIVE: The aim of the current study was to determine the independent clinical risk factors for predicting morphological severity of distal diabetic sensorimotor polynecuropathy (DSP) as determined by fiber density (FD) on sural nerve biopsy. RESEARCH DESIGN AND METHODS: A total of 89 patients with both type 1 and type 2 diabetes, ascertained from a large therapeutic randomized clinical trial, were included in this observational cohort study. Morphological severity of DSP was expressed as the myelinated FD in the sural nerve biopsy General linear models were used to assess the relationship between the morphological severity of DSP and various clinical risk factors. RESULTS: Glycated hemoglobin (GHb) was significantly related to FD in univariate and multivariate regression analyses. This relationship was present in models in which GHb was handled either as a continuous variable or as a categorical variable with the highest significance level, with a GHb cutoff level of 9%. After dividing patients into groups with optimal to moderate GHb < or = 9%) and suboptimal (GHb >9%) glycemic control, the difference in FD between the two groups ranged between 3,461 and 2,334 per mm2. FD was also significantly related to duration of diabetes and age of the patient. CONCLUSIONS: The severity of peripheral DSP expressed by morphological criteria was significantly related to glycemic control in type 1 and type 2 diabetic patients. Inconsistent with previously published electrophysiological data demonstrating a correlation between height and conduction velocity, increasing height is not associated with morphological severity. Based on the results of the present study, it might be hypothesized that improving glycemic control will lessen severity of DSP in terms of FD loss in subjects with diabetes.

Analysis of Variance↗

PubMed1992

Screening for diabetic retinopathy.

PURPOSE: To determine the appropriate patients, methods, and timing for screening for diabetic retinopathy. DATA SOURCES: Relevant articles were identified through prominent review articles, the authors' files, recommendations from experts, and a MEDLINE search (1986 to the present); additional references were selected from the bibliographies of identified articles. STUDY SELECTION: Selection of articles on the natural history of retinopathy was limited to large clinical series and formal epidemiologic studies of defined populations. Selection of articles on the therapeutic effect of photocoagulation and of glycemic control was limited to randomized trials. Sources bearing on the accuracy of screening modalities were necessarily more varied. DATA EXTRACTION: For important variables, individual estimates from multiple studies are presented rather than a single meta-analytic summary estimate. RESULTS: Screening for retinopathy is justifiable if early detection leads to less vision loss at an acceptable cost. The evidence shows that 1) laser therapy reduces the rate of vision loss by 50% among patients with proliferative retinopathy and macular edema, conditions that are often asymptomatic; 2) duration of diabetes is the main risk factor for retinopathy; and 3) standard ophthalmoscopic examination has only moderate sensitivity (about 80% in research settings) and specificity (greater than 90% for proliferative retinopathy but lower for macular edema), making seven-field stereophotography a more accurate method. Estimates of cost effectiveness indicate that screening for retinopathy not only saves years of vision but may be cost saving from a societal perspective. CONCLUSIONS: Screening for retinopathy in patients with diabetes, and subsequent photocoagulation therapy for those who have high risk macular edema or proliferative retinopathy, is clearly beneficial.

Cost-Benefit Analysis↗

PubMedDate not supplied

Personal models of diabetes among older adults: relationship to self-management and other variables.

The purpose of this study was to test whether older patients' personal models of diabetes predict their levels of self-management activities (dietary intake, physical activity, and blood glucose testing) and glycemic control. The Personal Models of Diabetes Interview (PMDI) was administered on two occasions to 78 patients (> or = 60 years) with non-insulin-dependent diabetes mellitus. Self-management behaviors, quality of life, and affect were assessed on the second occasion and at 4 months. Glycemic control was assessed at 4 months. Three constructs of the PMDI (cause, treatment effectiveness, and seriousness) were correlated significantly with several aspects of quality of life and with negative affect. Personal models, especially beliefs regarding treatment effectiveness, were predictive of dietary intake and physical activity but not blood glucose testing. Assessing patients' personal models is valuable for individualizing education and counseling for nutrition and physical activity, and selecting strategies consistent with patients' perspectives.

Aged↗

PubMed2003

C-reactive protein and glycemic control in adults with diabetes.

OBJECTIVE: Recent evidence suggests that poor glycemic control is significantly associated with the development of macrovascular complications of diabetes. Studies have indicated that C-reactive protein (CRP) is an important risk factor for cardiovascular disease. The purpose of this study was to determine the relation between CRP and HbA(1c) in a large national sample of individuals with diabetes. RESEARCH DESIGN AND METHODS: A nationally representative sample of noninstitutionalized U.S. adults aged 17 years and over with nongestational diabetes was derived from the National Health and Nutrition Examination Survey III (1988-1994) (n = 1,018). Respondents with diabetes were stratified by HbA(1c) level. The main outcome measure was elevated (>0.30 mg/dl) CRP. RESULTS: In unadjusted analyses, respondents with diabetes who had elevated HbA(1c) levels (> or =9.0%) had a significantly higher percent of elevated CRP than people with low (<7%) HbA(1c) levels (P < 0.001). In adjusted regression analysis, after controlling for age, race, sex, smoking, length of time with diabetes, insulin, and BMI, HbA(1c) was significantly associated with an increased likelihood of elevated CRP for HbA(1c) >9.0% (OR 2.15, 95% CI 1.07-4.32) and for HbA(1c) >11.0% (4.40, 1.87-10.38). Higher HbA(1c) also predicted elevated CRP in the regression model when HbA(1c) was analyzed as a continuous variable (1.20, 1.07-1.34). CONCLUSIONS: In this study, the likelihood of elevated CRP concentrations increased with increasing HbA(1c) levels. These findings suggest an association between glycemic control and systemic inflammation in people with established diabetes.

Adolescent↗

PubMed2006

Poor glycemic control increases risk of hospitalization in urban African Americans with diabetes.

OBJECTIVE: Hospitalizations due to diabetes are more frequent among African Americans, but risk factors are not known. We analyzed data from an urban African American patient population to identify variables associated with hospitalizations attributable principally to diabetes. DESIGN: Demographic, disease, and metabolic characteristics on patients seen in an outpatient diabetes clinic during 1991 to 1997 were extracted from an electronic patient tracking system. Data were linked to a statewide hospital discharge dataset to capture all in-state hospitalizations from 1998 to 2001. Persons who required a hospitalization for diabetes were compared to the remainder of individuals in the database. RESULTS: A total of 3397 diabetes patients (average age 56 years; 65% women; 92% African American) were included in the analysis; 12% had a hospitalization primarily due to diabetes. Persons with a diabetes hospitalization were younger and had diabetes longer, and fewer were women. In addition, persons who had a diabetes-related hospitalization had evidence of poorer glycemic control with higher hemoglobin A1C (HbA1C) levels. Both the absolute change and rate of decline in HbA1C was less in persons who were hospitalized. In adjusted analyses, duration of diabetes and HbA1C remained significantly associated with risk of a diabetes hospitalization. CONCLUSIONS: In this predominantly African American patient sample with diabetes, poorer glycemic control increased the chances of hospitalization due to diabetes. Continued efforts to aggressively control hyperglycemia could decrease the need for a diabetes hospitalization in this population.

Adolescent↗

PubMed1998

Dietary risk factors for colon cancer in a low-risk population.

In a 6-year prospective study, the authors examined the relation between diet and incident colon cancer among 32,051 non-Hispanic white cohort members of the Adventist Health Study (California, 1976-1982) who, at baseline, had no documented or reported history of cancer. The risk of colon cancer was determined from proportional hazards regression with adjustment for age and other covariates. The authors found a positive association with total meat intake (risk ratio (RR) for > or =1 time/week vs. no meat intake = 1.85, 95% confidence interval (CI) 1.19-2.87; p for trend = 0.01) and, among subjects who favored specific types of meat, positive associations with red meat intake (RR for > or =1 time/week vs. no red meat intake = 1.90, 95% CI 1.16-3.11; p for trend = 0.02) and white meat intake (RR for > or =1 time/week vs. no white meat intake = 3.29, 95% CI 1.60-6.75; p for trend = 0.006). An inverse association with legume intake (RR for >2 times/week vs. <1 time/week = 0.53, 95% CI 0.33-0.86; p for trend = 0.03) was observed. Among men, a positive association with body mass index was observed (relative to the RR for tertile III (>25.6 kg/m2) vs. tertile I (<22.5 kg/m2) = 2.63, 95% CI 1.12-6.13; p for trend = 0.05). A complex relation was identified whereby subjects exhibiting a high red meat intake, a low legume intake, and a high body mass experienced a more than threefold elevation in risk relative to all other patterns based on these variables. This pattern of putative risk factors would likely contribute to increases in both insulin resistance (high body mass, high red meat intake) and glycemic load (low legume intake), a synergism that, if causal, implicates hyperinsulinemic exposure in colon carcinogenesis. The overall findings from this cohort identify both red meat intake and white meat intake as important dietary risk factors for colon cancer and raise the possibility that the risk due to red meat intake reflects a more complex etiology.

Adult↗

PubMed2005

Genetics of diabetic nephropathy in type 2 DM: candidate gene analysis for the pathogenic role of inflammation.

Hypertension, poor glycemic control and albuminuria are well known risk factors for diabetic nephropathy, but these factors do not explain all of the inter-individual variabilities in the rate of progression to kidney failure. Recent evidence showed that genetic predisposition affected the hyperglycemia-induced nephrotoxicity in patients with type 2 diabetes mellitus (DM). We reviewed the present state of knowledge concerning the relationship between genetics and diabetic nephropathy in type 2 DM. However, the results are inconclusive and the genetic determinants of diabetic nephropathy are not fully understood. In addition, genetic background of nephropathy in type 2 DM was thought to be more complex than in type 1 DM. Recent studies suggested that the inflammation would be an essential component of type 2 DM and its complications. We postulated that increased systemic and/or intrarenal inflammation in high glucose milieu is important in the pathogenesis of nephropathy in patients with type 2 DM. To investigate the impact of inflammation on diabetic nephropathy, we studied several polymorphisms in genes encoding inflammatory cytokine and chemokine in patients with type 2 DM. Among them, -511 C/T in interleukin-1beta (IL-1beta), tandem repeat in IL-1 receptor antagonist (IL-1Ra), -308 G/A in tumour necrosis factor-alpha (TNF-alpha) were significantly associated with an increased risk of kidney failure. In addition, some of them were remarkably different from those previously reported in the NCBI or literature based on the western population. Our results suggest that inflammation could play a pathogenic role in diabetic nephropathy in type 2 DM. A better understanding of genetic factors predisposing to diabetic nephropathy would not only help to identify diabetic patients at risk, but also be helpful to unveil the pathogenesis of DN.

Cytokines↗

PubMed1997

Effects of a behavioral intervention on treatment adherence and stress management in adolescents with IDDM.

OBJECTIVE: To evaluate the effects of a behavioral program to increase treatment adherence and to improve stress management in adolescents with IDDM. RESEARCH DESIGN AND METHODS: A quasi-experimental pretest-posttest design with a nonequivalent control group was used. Eighteen subjects were assigned to the experimental group, which received the program, while nineteen subjects made up the control group, which received routine medical care. During the 12 intervention sessions with diabetic adolescents, different procedures were applied: instruction, blood glucose discrimination training, role-playing, relaxation exercises, self-instructions, problem-solving strategies, and homework, among others. RESULTS: The results show significant changes in the experimental group in variables related to diabetes information (patients and their parents), adherence, daily hassles, uneasiness and likelihood of response in social interactions, skills and frequency of glycemic analyses, blood glucose estimate errors, and negative family support (parents). The program had no effect on either dietary and physical exercise or glycemic control. The improvements, which were maintained at a follow-up carried out 13 months after finishing the program, were: patients' information about physiopathology (P = 0.000), diet (P = 0.000), physical exercise (P = 0.048), glucose testing (P = 0.030), and insulin (P = 0.000), barriers to adherence frequency (P = 0.000), severity of daily hassles (P = 0.006), and degree of uneasiness in social interaction (P = 0.000). CONCLUSIONS: This research introduces the novelty of integrating several behavioral procedures within a wide-ranging package that affects aspects implied in diabetes control such as treatment adherence and stress management. The testing of similar programs on samples of subjects with glycemic control difficulties would be useful.

Adolescent↗

PubMed2026

A GRADE-assessed systematic review and meta-analysis of randomized controlled trials evaluating the effects of olive leaf or olive pomace supplementation on cardiometabolic and anthropometric health markers.

AIMS: Cardiometabolic diseases (CMDs) are major contributors to global morbidity and mortality, and dietary bioactives such as polyphenols may modulate key risk factors. Olive by-products, particularly olive leaves (OL) and olive pomace (OP), are rich in phenolic compounds with antioxidant, anti-inflammatory, and cardiometabolic effects demonstrated across in vitro, preclinical, and clinical studies. DATA SYNTHESIS: This GRADE-assessed systematic review and meta-analysis included 30 randomized controlled trials (n = 1726) evaluating OL or OP supplementation on 21 standardized biomarkers, encompassing inflammatory markers, lipid profile, glycemic control, insulin sensitivity, anthropometric measures, and blood pressure. Meta-analyses were conducted using random-effects models, with effect sizes calculated as mean differences (or standardized mean differences for oxLDL). Between-study heterogeneity was assessed with I2 statistics, and sensitivity and subgroup analyses explored potential sources of variability. Publication bias was evaluated using Begg's test and funnel plots where appropriate. OL supplementation significantly improved lipid parameters (total cholesterol, triglycerides, LDL-C, ApoB, oxLDL) and increased ApoA1, while reducing TNF-α, systolic and diastolic blood pressure, body weight, and BMI. No significant effects were observed on glycemic markers. OP supplementation showed no consistent cardiometabolic benefits and was associated with an increase in IL-8. Certainty of evidence ranged from very low to high, with several outcomes downgraded due to imprecision, heterogeneity, or limited study numbers. CONCLUSION: These findings support the targeted use of OL as an adjunctive strategy for cardiometabolic risk management. Evidence for OP supplementation remains limited, underscoring the need for well-powered, high-quality RCTs to clarify its clinical effects.

Humans↗

PubMed1997

rhIGF-I administration reduces insulin requirements, decreases growth hormone secretion, and improves the lipid profile in adults with IDDM.

IDDM is associated with elevated circulating levels of growth hormone (GH) and reduced insulin-like growth factor I (IGF-I). GH antagonizes the action of insulin-increasing insulin requirements in IDDM. The effects of subcutaneously administered rhIGF-I on glycemic control, insulin requirements, and GH secretion were studied in eight adults with IDDM. Patients received either placebo or rhIGF-I (50 microg/kg b.i.d.) for 19 days in a randomized, double-blind, parallel-design, placebo-controlled trial. Overnight GH, plasma glucose, free insulin, IGF-I, fructosamine, and lipid profiles were assessed during this period. rhIGF-I therapy increased IGF-I concentration from 117.1 +/- 14.2 (mean +/- SE) ng/ml (baseline) to 310.5 +/- 40.6 and 257.1 +/- 41.2 ng/ml on day 5 (P < 0.01 vs. baseline) and day 20 (P < 0.01 vs. baseline), respectively. After 19 days of rhIGF-I treatment, fructosamine concentrations were unchanged compared with baseline (439 +/- 32 vs. 429 +/- 35 micromol/l, day -1 vs. day 20, respectively), yet insulin requirements were decreased by approximately 45% (0.67 +/- 0.08 vs. 0.36 +/- 0.07 U x kg(-1) x day(-1), day -1 vs. day 19, respectively, P < 0.005). After 4 days of rhIGF-I therapy, there was a decrease in free insulin levels (8.38 +/- 1.47 vs. 4.98 +/- 0.84 mU/l, P < 0.05), mean overnight GH concentration (12.6 +/- 3.3 vs. 3.8 +/- 2.1 mU/l, P = 0.05), and total cholesterol and triglycerides (4.68 +/- 0.31 vs. 4.25 +/- 0.35 mmol/l, P < 0.05, 1.27 +/- 0.19 vs. 0.95 +/- 0.21 mmol/l, P < 0.001, respectively). There was no change in any variable in the placebo-treated patients. This study demonstrates that subcutaneous administration of rhIGF-I decreases insulin requirements and improves the plasma lipid profile while maintaining glycemic control in adults with IDDM. The excess nocturnal release of GH, characteristic of IDDM, is also decreased by rhIGF-I therapy.

Adult↗

PubMed2004

Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with glimepiride: a twelve-month, multicenter, double-blind, randomized, controlled, parallel-group trial.

BACKGROUND: Glimepiride is approved as monotherapy and in combination with metformin or with insulin, whereas the combination of glimepiride with other antihyperglycemic drugs is under investigation. OBJECTIVE: The aim of this study was to assess the differential effect on glucose and lipid variables and tolerability of the combination of glimepiride plus pioglitazone or rosiglitazone in patients with type 2 diabetes mellitus (DM) and metabolic syndrome. METHODS: This 12-month, multicenter, double-blind, randomized, controlled, parallel-group trial was conducted at 3 study sites in Italy. We assessed patients with type 2 DM (duration, > or =6 months) and with metabolic syndrome. All patients were required to have poor glycemic control with, or to have experienced > or =1 adverse effect (AE) with, diet and oral hypoglycemic agents such as sulfonylureas or metformin, both given up to the maximum tolerated dose. All patients received a fixed oral dose of glimepiride, 4 mg/d divided into 2 doses, self-administered for 12 months. Patients also were randomized to receive oral pioglitazone (15 mg once daily) (G + P group) or oral rosiglitazone (4 mg once daily) (G + R group), self-administered for 12 months. We assessed body mass index (BMI), glycemic control (glycosylated hemoglobin [HbA(1c)], fasting and postprandial plasma glucose and insulin levels [FPG, PPG, FPI, and PPI, respectively], and homeostasis model assessment index), lipid profile (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], and triglycerides [TG]), and lipoprotein variables (apolipoprotein [apo] A-I and apo B) at baseline and at 3, 6, 9, and 12 months of treatment. Treatment tolerability was assessed at each study visit using a thorough interview of patients, and comparisons of clinical and laboratory values to baseline levels. RESULTS: A total of 91 patients were enrolled in the study; 87 patients completed it (G + P group: 24 women, 21 men; mean [SD] age, 53 [6] years; G + R group: 20 women, 22 men; mean [SD] age, 54 [5] years). Patients in the G + P and G + R groups experienced significant increases in mean BMI at 12 months compared with baseline (4.92% and 6.17%, respectively; both, P < 0.05). The combination of glimepiride with pioglitazone or rosiglitazone significantly improved glycemic control in the study patients. At 12 months, we observed a 1.3% improvement in mean values for plasma HbA(1c) concentration (P < 0.01) 19.3% in FPG (P < 0.01), 16.3% in PPG (P < 0.01), 42.4% in FPI ), and 23.3% in PPI (P <0.05); no significant differences were found between treatment groups. Although the G + P group experienced a significant improvement at 12 months in almost all variables of lipid metabolism from baseline (TC, - 11%; LDL-C, -12%; HDL-C, 15%; and apo B, - 10.6% [all, P , 0.05]), the G + R group experienced a significant increase in mostly the lipid risk factors for cardiovascular disease (TC, 14.9%; LDL-C, 16.5%; TG, 17.9%; and apo B, 10.3% [all, P , 0.05]). Overall, no statistically significant changes in plasma aminotransferase activities were observed. Of the 87 patients who completed the study, 6.7% (3/45) of patients in the G + P group and 11.9% (5/42) of patients in the G + R group had transient, mild to moderate AEs that did not cause withdrawal from the trial. CONCLUSION: In this study of patients with type 2 DM and metabolic syndrome who did not respond adequately to, or experienced AEs with, diet and either a sulfonylurea or metformin previously, the combination of glimepiride plus pioglitazone was associated with a significant improvement in lipid and lipoprotein variables, whereas the combination of glimepiride plus rosiglitazone appears to not have had any clinically significant effect on lipid metabolism.

Adult↗

PubMedDate not supplied

Oral infections and glycemic control in pregnant type 2 diabetics.

BACKGROUND: The relationship between diabetes mellitus and infection is bidirectional. Diabetes favors infection, while infections make controlling diabetes much more difficult. The most frequent infections encountered in pregnant diabetics are those of the urinary tract (UTI) and cervicovaginal (CVI) area. Periodontal diseases (PD) and active caries (AC) are infectious diseases frequently found in these cases often remaining as hidden entities of low intensity. The aim of this study was to assess whether there is an association between PD and caries with lack of glycemic control often encountered in pregnant type 2 diabetic women. METHODS: A single skilled researcher performed the periodontal evaluation of PD and AC cases. Glycated alpha hemoglobin (HbA(1c)) over 6.5% was used to diagnose metabolic glucose disturbances. The controlled variables were UTI, CVI and adherence to treatment. The statistical tests used were chi-square adjusted for continuity, analysis of variance, odds ratio with 95% confidence intervals and logistic regression with a significance level of p < 0.05. RESULTS: One hundred twenty-seven type 2 diabetic women were seen during the second trimester of their pregnancies. Mean age was 31.3 years; 55% had lack of glycemic control associated with CVI (chi2 21.07, p < 0.000), PD (chi2 5.72, p < 0.005) and UTI (chi2 13.77, p < 0.000) with therapeutic adherence (TA) (chi2 14.80, p < 0.00). No association was found with AC. The logistic regression results showed that UTI, CIV, PD and TA are associated with lack of glycemic control. CONCLUSIONS: Periodontal diseases may act as "hidden" infections in pregnant diabetics and be associated with lack of glycemic control. This situation should be taken into consideration by healthcare teams in charge of prenatal care.

Adult↗