Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With the Metabolic Syndrome

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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 prophylaxis for glucocorticoid-induced diabetes. Therefore the investigators will administer in males with the metabolic syndrome 30 mg prednisolone daily for two weeks and give simultaneously sitagliptin 100 mg daily. Subjects will undergo at baseline and after two weeks of treatment several tests to assess changes in glucose metabolism.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Glucocorticoids; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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