Status:
COMPLETED
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With the Metabolic Syndrome
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Diabetes Mellitus
Steroid Diabetes
Eligibility:
MALE
35-65 years
Phase:
NA
Brief Summary
The investigators will assess whether the DPP-inhibitor sitagliptin will ameliorate glucocorticoid-induced impairment of glucose metabolism and beta-cell dysfunction and thus could be used as a prophy...
Detailed Description
The investigators will conduct a randomized, placebo-controlled, double-blind, 2x2 factorial-designed intervention trial. The pharmacological intervention for prednisolone/prednisolone-placebo is 14 d...
Eligibility Criteria
Inclusion
- Caucasian males
- Modified from IDF criteria for the metabolic syndrome:
- Waist circumference ≥ 94 cm
- And at least 2 or more of the following criteria:
- TG ≥ 1.7 mmol/L
- HDL cholesterol \< 1.03 mmol/L
- Blood pressure \>130/85 mmHg (average of three measurements) or treatment of previously diagnosed hypertension
- Fasting plasma glucose level (FPG) ≥ 5.6 mmol/L (but no diabetes)
Exclusion
- 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)
- 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
- Diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l)
- Serious pulmonary, cardiovascular, hepatic (ALT, AST more than 3x ULN) or renal disease (serum creatinine \> 135 micromol/L)
- History of cardiovascular disease, such as myocardial infarction, cerebrovascular accident.
- Major psychiatric disorder, depression
- All diseases that induce changes in the hypothalamic-pituitary-adrenal (HPA) axis
- Malignant disease
- All other relevant medical disorders that potentially interfere with this trial.
- All medication interfering with study drug or interfering with study endpoints/hypotheses
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00721552
Start Date
October 1 2008
End Date
June 1 2012
Last Update
July 2 2012
Active Locations (1)
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1
VUmc Diabetes Center
Amsterdam, North Holland, Netherlands, 1081 HV