DZX Mediated Insulin Suppression in Obese Men

This study is not yet open for participant recruitment.

Verified by Rijnstate Hospital, February 2008

Sponsored by:	Rijnstate Hospital
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00631033

Purpose

The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.

Condition	Intervention	Phase
Obesity	Drug: Placebo Drug: Diazoxide Drug: Metformin + Diazoxide	Phase II

MedlinePlus related topics: Obesity

Drug Information available for: Insulin Metformin Metformin hydrochloride Diazoxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III

Further study details as provided by Rijnstate Hospital:

Estimated Enrollment:	90
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo
2: Experimental Diazoxide	Drug: Diazoxide
3: Experimental Metformin + Diazoxide	Drug: Metformin + Diazoxide

Eligibility

Ages Eligible for Study:	25 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male
age 25-50 years
BMI 30-35 kg/m2
stable body weight during 3 months before the start of the study
glucose <= 6.0 mmol/L
C-peptide >= 1.0 nmol/L
HbA1c <= 6.0%

Exclusion Criteria:

comorbidity
medication
serum creatinine > 120 micromol/L
liver enzymes > 2 times upper limits of normal
gout
alcohol use > 2 alcoholic drinks a day
drug abuse
cessation of smoking less than 6 months ago

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631033

Contacts

Contact: H de Boer, MD, PhD

+31 26 3786735

HdeBoer@alysis.nl

Locations

Netherlands
Rijnstate Hospital
Arnhem, Netherlands

Sponsors and Collaborators

Rijnstate Hospital

More Information

Study ID Numbers:	LTC-511-230108
Study First Received:	February 27, 2008
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00631033
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:

obesity
hyperinsulinism
diazoxide
metformin

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Hyperinsulinism
Diazoxide

Metformin
Nutrition Disorders
Overweight
Overnutrition
Insulin

Additional relevant MeSH terms:

Vasodilator Agents
Hypoglycemic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009