DZX Mediated Insulin Suppression in Obese Men

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Metformin + Diazoxide; Drug: Diazoxide

• Registration Number: NCT00631033
• Lead Sponsor: Rijnstate Hospital

Brief Summary

The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-03-07
• Study Start: 2008-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

• male
• age 25-50 years
• BMI 30-35 kg/m2
• stable body weight during 3 months before the start of the study
• glucose <= 6.0 mmol/L
• C-peptide >= 1.0 nmol/L
• HbA1c <= 6.0%

Exclusion Criteria

• comorbidity
• medication
• serum creatinine > 120 micromol/L
• liver enzymes > 2 times upper limits of normal
• gout
• alcohol use > 2 alcoholic drinks a day
• drug abuse
• cessation of smoking less than 6 months ago

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
3	Metformin + Diazoxide	Metformin + Diazoxide
2	Diazoxide	Diazoxide

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands