Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With the Metabolic Syndrome
SPHINX
2 other identifiers
interventional
82
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Oct 2008
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 24, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 2, 2012
June 1, 2012
3.7 years
July 22, 2008
June 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test.
14 days
Secondary Outcomes (9)
Incretin secretion during standardized meal test
14 days
Insulin sensitivity
14 days
Microvascular function: fasting and postprandial
14 days
Body composition, body fat distribution and intra organ fat accumulation
28 days
Molecular mechanisms in subcutaneous adipose tissue
14 days
- +4 more secondary outcomes
Study Arms (6)
I
EXPERIMENTALprednisolone + sitagliptin
II
EXPERIMENTALprednisolone + sitagliptin-placebo
III
EXPERIMENTALprednisolone-placebo + sitagliptin
IV
PLACEBO COMPARATORprednisolone-placebo + sitagliptin-placebo
Healthy controls
NO INTERVENTION12 healthy men will be included to assess postprandial microvascular function.
Type 2 diabetic subjects
NO INTERVENTION12 men with type 2 diabetes will be included in order to assess postprandial microvascular function.
Interventions
28 days administration of 100 mg daily
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VUmc Diabetes Center
Amsterdam, North Holland, 1081 HV, Netherlands
Related Publications (2)
van Genugten RE, van Raalte DH, Muskiet MH, Heymans MW, Pouwels PJ, Ouwens DM, Mari A, Diamant M. Does dipeptidyl peptidase-4 inhibition prevent the diabetogenic effects of glucocorticoids in men with the metabolic syndrome? A randomized controlled trial. Eur J Endocrinol. 2014 Feb 4;170(3):429-39. doi: 10.1530/EJE-13-0610. Print 2014 Mar.
PMID: 24297090DERIVEDvan Genugten RE, Serne EH, Heymans MW, van Raalte DH, Diamant M. Postprandial microvascular function deteriorates in parallel with gradual worsening of insulin sensitivity and glucose tolerance in men with the metabolic syndrome or type 2 diabetes. Diabetologia. 2013 Mar;56(3):583-7. doi: 10.1007/s00125-012-2783-y. Epub 2012 Nov 24.
PMID: 23178932DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michaela Diamant, Md PhD
VUmc Diabetes Center, Amsterdam, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. M. Diamant
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 24, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 2, 2012
Record last verified: 2012-06