Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

Obesity Clinical Trial

Official title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II

Status Completed

Clinical Trial Summary

The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

Clinical Trial Description

The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Study design:

This study is an open-labelled, non-randomized, phase IIa study.

Treatment:

During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.

Endpoints, monthly determined:

• body weight

• abdominal circumference

• body composition measured by Dual Energy X-ray Absorptiometry

• glucose tolerance ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperinsulinism
• Obesity

• NCT number: NCT00151684
• Study type: Interventional
• Source: Rijnstate Hospital
• Status: Completed
• Phase: Phase 2
• Start date: November 2004