Sitagliptin prophylaxis for glucocorticoid-induced impairment of glucose metabolism and beta-cell function in males with the metabolic syndrome-X: a randomized, placebo controlled, double blind, 2x2 factorial designed intervention trial.

Completed

• Conditions: Adverse effects of prednisolone; glucocorticoid-induced beta-cell dysfunction; 10018424; 10062915

• Registration Number: NL-OMON35611
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. signed informed consent
2. caucasian male
3. normal day-and night rythm
4. metabolic syndrome (according to IDF criteria):
Waist > 93 cm and at least 3 of the following criteria:
- triglycerides > 1.7 mmol/L
- HDL cholesterol < 1.03 mmol/L
- blood pressure > 130/85 mmHg
- disturbed glucose tolerance (definded as: fasting plasma glucose above 5.6 mmol/L, but no diabetes [see exclusion criteria]).

Exclusion Criteria

1. allergy for prednisolone
2. any other contra-indication for prednisolone use.
3. use of glucocorticoids in the past 3 months
4. Recent participation in a clinical trial
5. Blood donation in the past 3 months
6. (history of) alcohol or drugs abuse.
7. Not willing or able to sign the informed consent or not being able to understand the study information
8. serious (pulmonary, liver, kidney) diseases
9. history of cardiovascular disease (such as MI or CVA)
10. psychiatric disorder
11. depression
12. any condition that interferes with the HPA axis
13. malignancy
14. diabetes mellitus (defined as FPG * 7.0 mmol/l and/or 2hPG * 11.1 mmol/l)
15. other condition or usage of medication that may interfere with study endpoints of hypothesis. Eligibility will be assessed in each individual case by the research physician and internist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the effect of sitagliptin 100 mg daily versus placebo, given<br /><br>simultaneously with prednisolone 30 mg daily during 2 weeks, on<br /><br>glucocorticoid-induced glucometabolic abnormalities (measured as area-under the<br /><br>curve of postprandial glucose during a standardized mixed-meal test) in males<br /><br>with the metabolic syndrome. </p><br>