DZX Mediated Insulin Suppression in Obese Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Information provided by:
Rijnstate Hospital Identifier:
First received: February 27, 2008
Last updated: August 8, 2011
Last verified: August 2011

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
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:

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
Drug: Placebo
Experimental: 2
Drug: Diazoxide
Experimental: 3
Metformin + Diazoxide
Drug: Metformin + Diazoxide


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00631033

Contact: H de Boer, MD, PhD +31 26 3786735

Rijnstate Hospital Recruiting
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
  More Information

No publications provided 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:

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms
Antihypertensive Agents
Cardiovascular Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on October 20, 2014