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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00721552
Other study ID # DC2008Pred002
Secondary ID Eudract 2008-004
Status Completed
Phase N/A
First received July 22, 2008
Last updated June 28, 2012
Start date October 2008
Est. completion date June 2012

Study information

Verified date June 2012
Source VU University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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 days and for sitagliptin/sitagliptin-placebo 28 days. Subjects fulfilling the IDF criteria26 for the metabolic syndrome (aged 35-65; n=60) will be randomized to one of four groups: I) prednisolone 30 mg and sitagliptin 100 mg daily; II) prednisolone 30 mg and sitagliptin-placebo daily; III) prednisolone-placebo and sitagliptin 100 mg daily; IV) prednisolone-placebo and sitagliptin-placebo daily. Before and at day 14 of treatment subjects will undergo a standardized mixed-meal test in order to assess glucose disposal and beta-cell function (by modeling analysis). During these meal tests, plasma concentrations of (total and active) GLP-1, GIP, glucagon and additional biomarkers will be assessed. A combined hyperglycemic-euglycemic clamp will be performed at baseline and at day 13 of treatment to assess insulin sensitivity and insulin secretion. During the euglycemic clamp adipose tissue and muscle biopsies will be obtained, both in fasting and under hyperinsulinemic conditions. At baseline and at day 28 of treatment, a 7-point OGTT will be performed to assess time to restoration of glycemic control. Body composition, body fat distribution and liver fat content, measured by respectively bio-impedance analysis and magnetic resonance imaging/spectroscopy (MRI/MRS), will be assessed at baseline and after 28 days of treatment. Blood pressure will be assessed at baseline and after two weeks of treatment. Microvascular function will be assessed with capillary videomicroscopy both at baseline and after two weeks of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

Drug:
Sitagliptin 100 mg
28 days administration of 100 mg daily
Prednisolone 30 mg
14 days administration of 30 mg daily
Sitagliptin-placebo
28 days administration once daily
Prednisolone-placebo
14 days administration once daily

Locations

Country Name City State
Netherlands VUmc Diabetes Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test. 14 days No
Secondary Incretin secretion during standardized meal test 14 days No
Secondary Insulin sensitivity 14 days No
Secondary Microvascular function: fasting and postprandial 14 days No
Secondary Body composition, body fat distribution and intra organ fat accumulation 28 days No
Secondary Molecular mechanisms in subcutaneous adipose tissue 14 days No
Secondary Blood pressure and hemodynamic parameters 28 days No
Secondary Biomarkers such as lipoproteins, adipocytokines, and markers of systemic inflammation 14 days No
Secondary Time to recovery after cessation of the two-week prednisolone treatment 28 days No
Secondary Beta-cell function as determined by hyperglycemic clamp tests and modeling analysis from mixed-meal tests. 14 days No
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