DZX Mediated Insulin Suppression in Obese Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631033
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 6, 2014
Information provided by:
Rijnstate Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Drug: Placebo Drug: Diazoxide Drug: Metformin + Diazoxide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III
Study Start Date : July 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Diazoxide

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Placebo
Experimental: 2
Drug: Diazoxide
Experimental: 3
Metformin + Diazoxide
Drug: Metformin + Diazoxide

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00631033

Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital Identifier: NCT00631033     History of Changes
Other Study ID Numbers: LTC-511-230108
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Rijnstate Hospital:

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents