DZX Mediated Insulin Suppression in Obese Men

Sponsor
Rijnstate Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00631033
Collaborator
(none)
51
1
3
41
1.2

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Placebo

Drug: Placebo

Experimental: 2

Diazoxide

Drug: Diazoxide

Experimental: 3

Metformin + Diazoxide

Drug: Metformin + Diazoxide

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate Hospital Arnhem Netherlands

    Sponsors and Collaborators

    • Rijnstate Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00631033
    Other Study ID Numbers:
    • LTC-511-230108
    First Posted:
    Mar 7, 2008
    Last Update Posted:
    Nov 6, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 6, 2014