DZX Mediated Insulin Suppression in Obese Men

Obesity Clinical Trial

Official title:

Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631033
• Other study ID #: LTC-511-230108
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: November 5, 2014
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Placebo

• Diazoxide

• Metformin + Diazoxide

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands,