Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With… (NCT00721552) | Clinical Trial Compass
CompletedNot Applicable
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With the Metabolic Syndrome
Netherlands82 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range
35 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test.