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Biomedical subjects

J L Selam

Publications and source records attributed to J L Selam.

At least 55 records · Page 3Linked to original sources
PubMed1994

Alterations in reverse cholesterol transport associated with programmable implantable intraperitoneal insulin delivery.

Our previous studies have suggested that intraperitoneal (IP) insulin delivery may be associated with alterations of reverse cholesterol transport (RCT). We thus studied two parameters of RCT. We performed RCT studies in 10 C-peptide-negative type I diabetic patients who were randomized into two groups. The experimental (A) and control (B) groups were studied at -3 and 0 months before and +3 and +6 months after IP pump subcutaneous (SC) insulin use. The first step in RCT was estimated by measuring patient serum-mediated 3H-cholesterol efflux from cultured fibroblasts. Cholesteryl ester transport protein (CETP) activity was assessed by a solid-phase assay. No changes in glucose control occurred during the study. Total low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, apoprotein B, and apoprotein A-I remained unchanged during the study. Cholesterol efflux from group A increased from baseline after 3 months of IP insulin by 9.5% +/- 3.4% (mean +/- SE, P < .05), whereas in group B patients it decreased negligibly by 1.5% +/- 2.9% (P = .045 for changes between groups). CETP activity increased from baseline by 25.3% +/- 7.7% (P < .05) in group A after 3 months of IP insulin, whereas in group B it changed little, -1.5% +/- 7.9%, with modest differences between groups (P = .16). These data indicate that (1) serum from patients treated long-term with IP insulin delivery may enhance cholesterol efflux from fibroblasts and CETP activity, and (2) these effects appear independent from glucose control, implying a direct effect by IP insulin.

Adult↗
PubMed1994

Insulin antibody responses after long-term intraperitoneal insulin administration via implantable programmable insulin delivery systems.

OBJECTIVE: To determine whether insulin antibodies are generated in diabetic patients after short- and long-term intraperitoneal insulin use and, if so, whether they are of potential clinical interest. Insulin antibodies commonly develop in diabetic patients who use subcutaneous human insulin, although their clinical significance remains controversial. Few data are available regarding insulin antibody responses to intraperitoneal insulin. RESEARCH DESIGN AND METHODS: We studied insulin antibody levels and clinical diabetes control in 25 type 1 diabetic patients treated for 3-6 years with intraperitoneal surfactant-stabilized porcine modified human insulin delivered by implantable programmable insulin delivery systems. RESULTS: All patients had preimplantation insulin antibody levels < 20 microU/ml, with a mean value of 2 +/- 2 microU/ml (1 SD). Mean antibody levels increased throughout the study period to a mean maximum of 197 +/- 326 microU/ml (P < 0.02) with 11 of 25 (44%) patients' levels exceeding 20 microU/ml (insulin responders). The mean time to significant antibody development was 21.8 +/- 4.4 months. Of the 11 responder patients, 4 had clinical syndromes that consisted of increasing daily insulin requirements and/or nocturnal hypoglycemia despite minimal nighttime basal insulin infusion rates associated with peak antibody levels > 200 microU/ml. None of the nonresponder patients (antibody levels < 20 microU/ml) had these clinical findings. CONCLUSIONS: Our results indicate that insulin antibody levels observed during intraperitoneal administration of human insulin are 1) similar to those reported during subcutaneous administration; although the rise in antibody level may be delayed compared with subcutaneous human insulin, 2) associated with a patient subset who are insulin antibody responders after switching from subcutaneous to intraperitoneal human insulin, 3) associated with a decrease in levels among responder patients regardless of whether they discontinue or continue pump use, and 4) associated with increased insulin needs and/or nocturnal hypoglycemia despite minimal basal rate insulin infusion at nighttime when antibody levels exceed 200 microU/ml.

Adult↗
PubMed1994

A cost-benefit comparison of intensive diabetes management with implantable pumps versus multiple subcutaneous injections in patients with type I diabetes.

OBJECTIVE: To investigate if intraperitoneal (IP) insulin infusion via programmable implantable pumps is a potential alternative to subcutaneous (SC) insulin via multiple injections. RESEARCH DESIGN AND METHODS: We compared the cost-benefits of the two methods using a randomized, prospective, 6-month, crossover design in 10 adult type I diabetic patients. RESULTS: When judged on the last month of IP versus SC periods in the nine patients who completed the study, metabolic data showed better glycemic control (HbA1c: 7.2 +/- 0.2 IP vs. 8.5 +/- 0.7% SC, mean +/- SE, P = 0.02), reduced glycemic fluctuations (SD of capillary glucose values: 3.4 +/- 0.2 IP vs. 4.6 +/- 0.2 mM SC, P < 0.01), and fewer mild hypoglycemic events (5.7 +/- 2.0 IP vs. 10.0 +/- 3.1 events/month SC, P = 0.02). Quality of life, judged by Diabetes Control and Complications Trial questionnaires, was unaffected by pump therapy. Direct costs, including pump acquisition, implantation, and follow-up, were 2.6-fold higher with IP than with SC delivery. CONCLUSIONS: The implantable pump is more effective in the short term, equally accepted, but more costly than multiple injections and should be limited to patients with unsatisfactory glycemic control despite intensive diabetes management with SC insulin. In addition, longer-term, larger-scale, and comparative evaluation is required.

Adult↗
PubMed1993

The use of glipizide combined with intensive insulin treatment for the induction of remissions in new onset adult type I diabetes.

To determine if glipizide could enhance remission induction in new onset type 1 diabetes compared to intensive insulin treatment alone, 27 patients with type 1 diabetes were intensively treated in an open randomized trial with subcutaneous injections for one month. The insulin was randomly either discontinued (Group A) or the insulin discontinued and glipizide begun (Group B) Three patients in Group A (22%) and 7 in Group B (54%, p < .05) underwent insulin-free remissions for 10.3 +/- 4.4 and 8.7 +/- 2.6 months, respectively (p = NS). Mean blood glucose levels during insulin treatment were lower in patients entering remissions (94 +/- 3 mg/dl versus 102 +/- 5 mg/dl, p < 0.05). C-peptide levels were performed 0, 4, 8, and 24 weeks after insulin treatment. When all patients were examined, mean stimulated C-peptide levels at 4 weeks (0.58 +/- 0.09 pm/ml) were increased compared to time 0 (0.32 +/- 0.05 pm/ml, p < 0.02). Patients not entering remission had higher 4-week stimulated values (0.67 +/- 0.12 pm/ml) compared to time 0 values (0.29 +/- 0.06 pm/ml, p < .01), whereas remission patients' mean C-peptide levels remained similar at 0, 4, 8 and 24 weeks. These data indicate that a) insulin treatment plus glipizide induces higher rates of remission compared to intensive insulin treatment alone, b) the intensity of initial metabolic control may be an important determinant for remission induction, and c) endogenous insulin secretion is not associated with remission induction, suggesting that glipizide alters insulin sensitivity or is immunomodulatory in the context of new onset type 1 diabetes.

Adult↗
PubMed1993

Long-term safety and efficacy of programmable implantable insulin delivery systems.

OBJECTIVES: Since only short-term studies of continuous intraperitoneal insulin infusion (CIPII) therapy using implantable programmable insulin delivery systems have been performed to show this method of diabetes therapy to be safe and efficacious, we have performed long-term studies to assess its safety and efficacy. RESEARCH DESIGN AND METHODS: For 78 patient-years of follow-up, we have longitudinally studied the incidence of diabetic ketoacidosis and severe hypoglycemia in 25 type 1 diabetic patients treated with CIPII. We also compared, cross-sectionally, the long-term safety and efficacy of CIPII to intensive subcutaneous insulin therapy using intermittent injections or continuous subcutaneous insulin infusion. Finally, we examined the relationship between glycated hemoglobin levels and the standard deviation of daily blood glucose excursion. RESULTS: Cross-sectional analysis revealed similar degrees of metabolic control accompanied by significantly decreased rates of both ketoacidosis (0.013 events/patient/year) and severe hypoglycemia (0.05 events/patient/year) during CIPII compared to intermittent injections and continuous subcutaneous insulin infusion therapy. A four-fold decrease in the rate of severe hypoglycemia was observed during longitudinal comparison of pre- and post-implantation complication rates. A relationship was also shown between decreased levels of mean glycated hemoglobin and the standard deviation of blood glucose excursions during CIPII therapy. CONCLUSIONS: Our data demonstrate that long-term therapy with CIPII is as effective as other methods in achieving near-normal levels of glycated hemoglobin, which in CIPII is associated with a decreased standard deviation of blood glucose excursions. Further, CIPII using implantable programmable insulin delivery systems is the safest method described for intensive insulin therapy in home blood glucose monitoring type 1 diabetic patients.

Adolescent↗
PubMed1993

[Cost benefits of intensive insulin therapy using injections, external pumps and implantable pumps].

Since feasibility is now proven, cost-efficacy of external sub-cutaneous (EXT) and implantable programmable (IMP) insulin pumps needs to be compared to those of intensified conventional insulin therapy (CONV). Only metabolic efficacy and short-term direct costs are easily evaluable. We (WHO-CSII Study) and others have shown that glycemic control and severe hypoglycemia risk are slightly improved, while ketoacidosis risk and costs are aggravated with EXT vs CONV. We (CEDIT Study) and others have shown that glycemic control, mild and severe hypoglycemic risks are improved, with no increase in ketoacidosis rates although a doubling in costs with IMP vs CONV. Rigid interpretation of the above data would limit indications of insulin pumps to patients experiencing frequent hypoglycemias while on intensified conventional insulin therapy.

Blood Glucose↗
PubMed1992

[Insulin administration systems. Possibilities and difficulties].

Conventional insulin therapy, particularly when intensive, dose not provide all the comfort and effectiveness desired. The new insulin therapy methods that are, or will soon be, available are described in this review paper. The new types of subcutaneous insulin administration include the so-called "fountain-pens"--in fact ready-to-use syringes--and portable insulin pumps, which are helpful to some patients. Pancreas and islets transplantations are limited by the problem of tissue harvesting and by the necessity of chronic immunosuppression. Nasal insulin sprays will replace rapid insulin injections when the problem of bioavailability is solved and the lack of toxicity is demonstrated. The implantable artificial pancreas is still awaiting the development of long-term reliable glucose sensors, but one of its elements, the implantable insulin pump, is already operational; its safety and reliability have now been proven; its effectiveness seems to result from a better stabilization of blood glucose level variations; it will not supersede conventional injections, but it is the only alternative for patients with poor glycaemia control and notably for those at high risk of hypoglycaemia.

Administration, Inhalation↗
PubMed1992

[Administration of insulin in type 1 diabetes].

Insulin therapy by subcutaneous injection is not satisfactory: it rarely brings down glycaemia to its normal level, exposes to the risk of hypoglycaemia and hyperinsulinism, is difficult to endure for a long period and requires full patient's involvement. Improvements are being achieved in the route of insulin administration (intraperitoneal and nasal routes), the type of insulin (analogues) and the material used to administer the hormone (insulin pens and implantable pumps).

Diabetes Mellitus, Type 1↗
PubMed1992

Implantable programmable insulin pumps for the treatment of diabetes.

Implantable programmable pump systems for insulin delivery to the peritoneal cavity or for intravenous insulin delivery have been recently developed. Thirty-one pumps were implanted in 25 patients between 1987 and 1991. At this writing, 76% of patients had functioning pumps. Ninety-two percent of pumps were functioning at 1 year; 89% at 2 years; and 50% at 3 years. No life-threatening complications, either surgical or metabolic, developed. However, 18 patients required 23 outpatient procedures for maintenance of pump function or for pump removal. Metabolic improvement was evidenced by mean and standard deviation of blood glucose levels and by glycosylated hemoglobin levels.

Abdominal Muscles↗
PubMed1992

Exercise is not associated with better diabetes control in type 1 and type 2 diabetic subjects.

In the clinical setting, the impact of educational efforts on the amount of regular exercise and its effects on diabetes control are unclear. Fifty type 1 diabetic, 50 type 2 diabetic and 70 non-diabetic subjects were evaluated using a questionnaire for type, duration and intensity of exercise to assess weekly energy expenditure. Diabetic subjects did not exercise more than controls: 36% of the type 1, 46% of the type 2 and 46% of the control subjects admitted no physical activity, and those exercising regularly had similar energy expenditure: 1808 +/- 320, 2722 +/- 617, 2523 +/- 304 (mean +/- SEM) kcal/week respectively (P = NS). There was no correlation between the degree of activity and HbA1c levels, or hypoglycaemic events. HbA1c levels were less than 6,8% in 31% of nonactive patients versus 21% of active patients (P = NS). A negative correlation was found between physical activity and daily insulin usage (r = 0.27, P less than 0.05), but differences between patients averaged only 4IU/1000 kcal energy expenditure/day. We conclude that patients' attitude towards exercise was not improved by our educational methods and that physical exercise was not necessarily associated with good blood glucose control.

Body Mass Index↗
PubMed1992

Randomized comparison of metabolic control achieved by intraperitoneal insulin infusion with implantable pumps versus intensive subcutaneous insulin therapy in type I diabetic patients.

OBJECTIVE: To compare intraperitoneal implantable insulin infusion (IP) to subcutaneous (SC) intensive insulin therapy. RESEARCH DESIGN AND METHODS: Twenty-one insulin-dependent (type I) diabetic patients aged 24-61 yr underwent a 3-mo treatment optimization using multiple SC daily injections or external pumps. Patients were then randomized (time 0 mo) to IP infusion using Infusaid-programmable pumps or continuation on SC intensive insulin for 6 mo. RESULTS: No differences were noted between study and control group data. However, longitudinal within-group comparisons from baseline showed that glycosylated hemoglobin improved to near-normal in both groups: IP, 9.0 +/- 0.5 vs. 7.8 +/- 0.6% (P less than 0.05) and SC, 8.4 +/- 0.5 vs. 7.5 +/- 0.3% (P less than 0.5) at 0 and 4 mo, respectively (normal less than 6.9%). The percentage of blood glucose tests greater than 11 mM at 0 and 6 mo was 28 +/- 5 vs. 16 +/- 4% in the IP group (P less than 0.05) and 22 +/- 5 vs. 24 +/- 7% in the SC group (NS). At 0 and 6 mo, the standard deviation of blood glucose values, an index of glycemic fluctuations, was 4.3 +/- 0.4 vs. 3.2 +/- 0.5 mM in the IP group (P less than 0.05) and 3.7 +/- 0.3 vs. 4.0 +/- 0.4 mM in the SC group (NS). Weight, insulin dosages, circulating lipid levels, and the frequency of severe hypoglycemic reactions and biochemical hypoglycemias were similar and did not change in the two groups. CONCLUSIONS: IP-implantable pumps compared with SC intensive insulin therapy have similar effects on most metabolic variables and are equally effective at achieving near-normal glycemic levels. Only longitudinal data suggest that IP treatment may be more effective at limiting glycemic fluctuations.

Adult↗
PubMed1992

Clinical trial of programmable implantable insulin pump for type I diabetes.

OBJECTIVE: The first step in the evolution of an artificial pancreas is the development of a reliable implantable pump for insulin delivery. Despite recent advances, significant issues remain, including small size of studies and frequent irreversible catheter obstructions. We report safety, feasibility, and efficacy results from 56 patients, representing 73 patient-yr of pump experience, entered into a multicenter trial with a new implantable programmable pump. RESEARCH DESIGN AND METHODS: All patients had insulin-dependent (type 1) diabetes, were 38 +/- 8 yr old, and were not prone to severe hypoglycemia. The pump (Infusaid 1000) has a pulsatile mechanism powered by freon-vapor pressure. Its rate is regulated by battery-powered valves, operated via a hand-held programmer. The pump is refilled transcutaneously with 25 ml U100 insulin (Hoechst 21PH) on a monthly basis and has a second septum (side port) proximal to the catheter, which allows flushing the catheter or lavaging the pump unit. The pumps were implanted after 3 mo intensive subcutaneous insulin therapy and catheters were positioned either in the peritoneum (i.p., n = 38) or the superior vena cava (i.v., n = 18). RESULTS: All implanted pumps have functioned safely with no instance of overdelivery or stoppage. The most frequent complications were flow slow downs, presumably due to insulin precipitation within the pump, which occurred in 86% of pumps and were resolved in all but one case by lavaging the pump in situ with alkaline solution. Flow slow downs due to catheter obstruction occurred in 52% of the intravenous catheters but only 21% of the intraperitoneal catheters (P less than 0.05) and were resolved in all but two cases by diluent flushing through the sideport. Incidence of severe hypoglycemia decreased from 0.47 before implant to 0.05 episodes/patient-yr after pump implantation (P less than 0.001). Mean HbA1c fell from 7.4 +/- 1.2% after intensive subcutaneous therapy to 7.1 +/- 1.0% 12 mo after implantation. Only 2 patients withdrew from study after recurrent catheter problems, and quality-of-life questionnaires showed improvement in satisfaction with diabetes-specific quality of life when on implantable pump therapy. CONCLUSIONS: Insulin therapy with implantable pumps is effective and safe for periods up to 1.7 yr with a decreased risk of severe hypoglycemia than with intensive subcutaneous insulin therapy.

Adult↗