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Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

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ClinicalTrials.gov Identifier: NCT00151684
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
Rijnstate Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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 : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Diazoxide
U.S. FDA Resources




Primary Outcome Measures :
  1. body weight
  2. abdominal circumference
  3. body composition measured by Dual Energy X-ray Absorptiometry
  4. glucose tolerance


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00151684     History of Changes
Other Study ID Numbers: LTC-268-060504
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Rijnstate Hospital:
Obesity
Hyperinsulinism
Diazoxide

Additional relevant MeSH terms:
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diazoxide
Antihypertensive Agents
Vasodilator Agents