Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00151684
First received: September 8, 2005
Last updated: February 27, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Obesity
Hyperinsulinism
Drug: Diazoxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • body weight
  • abdominal circumference
  • body composition measured by Dual Energy X-ray Absorptiometry
  • glucose tolerance

Estimated Enrollment: 25
Study Start Date: November 2004
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
  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151684

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Hans de Boer, MD PhD Rijnstate Hospital, Arnhem, The Netherlands
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151684     History of Changes
Other Study ID Numbers: LTC-268-060504
Study First Received: September 8, 2005
Last Updated: February 27, 2008
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:
Obesity
Hyperinsulinism
Diazoxide

Additional relevant MeSH terms:
Hyperinsulinism
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diazoxide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on August 18, 2014