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DZX Mediated Insulin Suppression in Obese Men

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ClinicalTrials.gov Identifier: NCT00631033
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 6, 2014
Sponsor:
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
Placebo
Drug: Placebo
Experimental: 2
Diazoxide
Drug: Diazoxide
Experimental: 3
Metformin + Diazoxide
Drug: Metformin + Diazoxide




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

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 ClinicalTrials.gov identifier (NCT number): NCT00631033


Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital

ClinicalTrials.gov 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:
obesity
hyperinsulinism
diazoxide
metformin

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