Diazoxide Injection |
Hyperstat IV |
Clinical Trial: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
This study is currently recruiting patients.
Verified by Rijnstate Hospital September 2005
|
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 II |
MedlinePlus related topics: Metabolic Disorders; Obesity
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
Expected Total Enrollment: 25
Study start: 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
Eligibility
Accepts Healthy Volunteers
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
Location and Contact Information
Netherlands
Rijnstate Hospital, ARNHEM, Netherlands; Recruiting
Gerben AJ van Boekel, MD 0031-26-3788888 GvanBoekel@alysis.nl
Gerben AJ van Boekel, MD, Sub-Investigator
Hans de Boer, MD PhD, Principal Investigator, Rijnstate Hospital, Arnhem, The Netherlands
More Information
Publications
Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45.
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00151684
Health Authority: Netherlands: Dutch Health Care Inspectorate
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Diazoxide Injection (Drug Digest)
- Hyperstat IV (Drug Digest)

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