Hyperinsulinemic men with BMI 30-35 kg/m2 MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Trade Name: Proglicem
Product Name: Proglicem
Product Code: RVG 06865
Pharmaceutical Form: Capsule*
INN or Proposed INN: DIAZOXIDE
CAS Number: 364987
Current Sponsor code: RVG 06865
Concentration unit
Sponsors
Rijnstate Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Men -BMI 30-35 kg/m2 -Age 25-50 years -Healty -Stable body weight 3 months before participating in study -Fasting glucose = 6.0 mmol/L -Fastinge C-peptide = 1.0 nmol/L or in upper quartile of normal -HbA1c = 6.0% -No co-medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -creatinin > 120 µmol/L -Liver enzyms > 2x upper limit of normal -Gout -Alcohol > 2E/day -Drugs abuse -Cessation of smoking less than 6 months before participating in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether metformin has additional value in treatment of obesity by diazoxide mediated insulin suppression. ;Secondary Objective: Is amount of weight reduction related to decrease in insulin? Is fasting insulin level a good predictor of after meal values? ;Primary end point(s): -Body weight (kg) -Waist circumference (cm) -Body composition measured by DEXA (Dual Energy X-ray Absorptiometry) (kg) and separetely measurements of abdominal fat (kg) -Fasting glucose and insulin -Glucosetolerance measured by 8 points glucose curve, HbA1c and meal test -Compliance to advise of physical exercise by step measurements. | — |
Countries
Netherlands
Outcome results
None listed