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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151684
• Other study ID #: LTC-268-060504
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: February 27, 2008
• Start date: November 2004

Study information

• Verified date: February 2008
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• fasting glucose < 7.0 mmol/L

• fasting C-peptide plasma level > 1.0 nmol/L

• HbA1c of 6.0% or lower

• Absence of comorbidity

• Absence of medication use

Exclusion Criteria:

• Plasma Creatinine > 120 micromol/L

• Liverenzymes > 2 times the upper normal limit

• Gout

• Alcohol use > 2 units/day

• Illicit drug use

• Quit smoking less than 6 months ago

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

Intervention

Drug:
• Diazoxide

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight
Primary	abdominal circumference
Primary	body composition measured by Dual Energy X-ray Absorptiometry
Primary	glucose tolerance