Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151684

Enrollment

Registered

2005-09-09

Start date

2004-11-30

Completion date

Unknown

Last updated

2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Hyperinsulinism

Keywords

Obesity, Hyperinsulinism, Diazoxide

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.

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

Interventions

DRUGDiazoxide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
body weight	—
abdominal circumference	—
body composition measured by Dual Energy X-ray Absorptiometry	—
glucose tolerance	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026