Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00151684
• Collaborator: (none)
• Enrollment: 25
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Hyperinsulinism	Drug: Diazoxide	Phase 2

Detailed 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

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
• Study Start Date: Nov 1, 2004

Outcome Measures

Primary Outcome Measures

1. body weight []

2. abdominal circumference []

3. body composition measured by Dual Energy X-ray Absorptiometry []

4. glucose tolerance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem		Netherlands

Sponsors and Collaborators

• Rijnstate Hospital

Investigators

• Principal Investigator: Hans de Boer, MD PhD, Rijnstate Hospital, Arnhem, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00151684
• Other Study ID Numbers: LTC-268-060504
• First Posted: Sep 9, 2005
• Last Update Posted: Feb 29, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Obesity; Hyperinsulinism; Diazoxide
• Additional relevant MeSH terms: Hyperinsulinism; Diazoxide

Study Results

No Results Posted as of Feb 29, 2008