MedTrace Logo

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

NCT00721552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-07-02

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus
  • Steroid Diabetes
  • Glucocorticoid-induced Diabetes
  • Beta-cell Function

Interventions

DRUG

Sitagliptin 100 mg

28 days administration of 100 mg daily

DRUG

Prednisolone 30 mg

14 days administration of 30 mg daily

DRUG

Sitagliptin-placebo

28 days administration once daily

DRUG

Prednisolone-placebo

14 days administration once daily

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Michaela Diamant, Md PhD · VUmc Diabetes Center, Amsterdam, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00721552 on ClinicalTrials.gov