Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
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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 |
- body weight
- abdominal circumference
- body composition measured by Dual Energy X-ray Absorptiometry
- glucose tolerance
Estimated Enrollment: | 25 |
Study Start Date: | November 2004 |
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
Ages Eligible for Study: | 30 Years to 50 Years |
Genders 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
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 October 16, 2012