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| Sponsored by: |
Grill, Valdemar, M.D. |
|---|---|
| Information provided by: | Grill, Valdemar, M.D. |
| ClinicalTrials.gov Identifier: | NCT00131755 |
Purpose
The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: diazoxide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing Beta-Cell Demise in Newly Diagnosed Type 1 Diabetes |
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | June 2008 |
At the time of diagnosis most subjects with type 1 diabetes retain significant endogenous insulin secretion as assessed by C-peptide measurements. Although not sufficient for the needs of the individual, residual insulin secretion is important for metabolic control, for avoidance of hypoglycemic episodes and, perhaps, for protection against diabetic complications. To retain residual endogenous insulin secretion in type 1 diabetes is thus highly desirable.
Residual insulin secretion deteriorates during the course of type 1 diabetes. The underlying autoimmune process is a major determinant of deterioration.
However, also measures that do not directly target the immune system could be beneficial. The DCCT study randomised subjects with type 1 diabetes to either intensive or conventional insulin treatment. The intensive insulin treatment markedly retarded deterioration in C-peptide levels during 5 years of observation. The favourable effect could be due to lesser hyperglycemia per se. Alternatively, the effect of intensive insulin treatment could be secondary to lesser degree of over-stimulation of the patients' beta-cells.
It is by now established that relief from over-stimulation by diazoxide favourably affects beta-cell function and that such treatment can retard a decline in residual insulin secretion in subjects with newly diagnosed type 1 diabetes. Diazoxide has been used in clinical practice for > three decades without major safety concerns.
Disturbing, albeit reversible, side effects are halting long-term studies with diazoxide in type 1 diabetes. The researchers find that lower and intermittent (i.e. night time) dosing of diazoxide produces no measurable side effects in subjects with type 2 diabetes.
This is a double blinded placebo controlled study, with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months. The patients will be followed up after intervention for at least 12 months.
Beta cell function and glycemic control will be monitored.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| University Hospital of Trondheim | |
| Trondheim, Norway, 7006 | |
| Principal Investigator: | Grill Valdemar, MD PhD | Norwegian University of Science and Technology |
More Information
| Study ID Numbers: | DIAZ 1, Eudract 2004-004103-38 |
| Study First Received: | August 17, 2005 |
| Last Updated: | September 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00131755 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
type 1 diabetes beta cell rest diazoxide insulin secretion |
|
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diazoxide Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
|
Vasodilator Agents Immune System Diseases Therapeutic Uses |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
