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Completed

NCT Number: NCT00151684

Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Rijnstate Hospital

Arnhem, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazoxide

Drug

Primary outcomes

  1. body weight

  2. abdominal circumference

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

  4. glucose tolerance

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
First posted
Sep 9, 2005
Registry last updated
Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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