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DZX Mediated Insulin Suppression in Obese Men

This study is currently recruiting participants.
Verified August 2011 by Rijnstate Hospital
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00631033
First received: February 27, 2008
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Estimated Enrollment: 90
Study Start Date: July 2008
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Placebo
Experimental: 2
Diazoxide
 Drug: Diazoxide
Experimental: 3
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 Recruiting
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00631033     History of Changes
Other Study ID Numbers: LTC-511-230108
Study First Received: February 27, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
obesity
hyperinsulinism
diazoxide
metformin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diazoxide
Metformin
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013