| Trial ID: | L5725 |
| Source ID: | NCT00721552
|
| Associated Drug: |
Sitagliptin 100 Mg
|
| Title: |
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism in Males With the Metabolic Syndrome
|
| Acronym: |
SPHINX
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Steroid Diabetes|Glucocorticoid-induced Diabetes|Beta-cell Function
|
| Interventions: |
DRUG: Sitagliptin 100 mg|DRUG: Prednisolone 30 mg|DRUG: Sitagliptin-placebo|DRUG: Prednisolone-placebo
|
| Outcome Measures: |
Primary: Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test., 14 days | Secondary: 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|Blood pressure and hemodynamic parameters, 28 days|Biomarkers such as lipoproteins, adipocytokines, and markers of systemic inflammation, 14 days|Time to recovery after cessation of the two-week prednisolone treatment, 28 days|Beta-cell function as determined by hyperglycemic clamp tests and modeling analysis from mixed-meal tests., 14 days
|
| Sponsor/Collaborators: |
Sponsor: Amsterdam UMC, location VUmc
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
82
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-10
|
| Completion Date: |
2012-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-07-02
|
| Locations: |
VUmc Diabetes Center, Amsterdam, Noord-Holland, 1081 HV, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00721552
|
