Glucocorticoid-induced Beta-cell Dysfunction Clinical Trial
— PREDEXOfficial title:
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers
The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in healthy subjects.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - written informed consent - 18 years = age = 35 years on the day of the first visit - 22.0 = BMI = 28.0 kg/m2 - (History of) good physical and mental health as determined by history taking, physical and laboratory examinations and ECG. - fasting glucose level of < 5.6 mmol/L, in addition to a glucose level of < 7.8 mmol/L at 2 hours after intake of 75 g glucose (OGTT). - able to keep a normal day and night rhythm during the trial period (i.e. no shift work) Exclusion Criteria: - history or presence of a medical disorder - use of drugs, except for incidental (non-opioid) analgesic agents - first degree relative with T2DM - performing intensive physical activity > 1x/week - an allergic or anaphylactic reaction to prednisolone treatment in the past - clinically relevant history or presence of any medical disorder, which are mentioned in the Summary of Product Characteristics (SPC) as contraindication for the use of prednisolone - glucocorticosteroid use during the last three months prior to the first dose - participation in an investigational drug trial within 90 days prior to the first dose - donation of blood (> 100 mL) within 90 days prior to the first dose - history of or current abuse of drugs or alcohol (>14 U/week) - smoking - use of grapefruit products during the study period - recent changes in weight and/or physical activity - serious mental impairment or language problems i.e. preventing to understand the study protocol/aim |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | VU University Medical Center | Amsterdam | Noord-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| VU University Medical Center | National Research Council, Institute of Biomedical Engineering |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism in healthy males, quantified as glucose tolerance (AUCgluc) during a standardized mixed-meal test | Single-day treatment | No | |
| Secondary | To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced acute beta-cell dysfunction in healthy males, quantified as Various measures of beta-cell function | Single day treatment | No |