DZX Mediated Insulin Suppression in Obese Men
Overview[ - collapse ][ - ]
| 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 | Obesity |
| Intervention | Drug: Placebo Drug: Diazoxide Drug: Metformin + Diazoxide |
| Phase | Phase 2 |
| Sponsor | Rijnstate Hospital |
| Responsible Party | Rijnstate Hospital |
| ClinicalTrials.gov Identifier | NCT00631033 |
| First Received | February 27, 2008 |
| Last Updated | August 8, 2011 |
| Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 27, 2008 |
|---|---|
| Last Updated Date | August 8, 2011 |
| Start Date | July 2008 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | DZX Mediated Insulin Suppression in Obese Men |
|---|---|
| Official Title | Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Obesity |
| Intervention | Drug: Placebo Drug: Diazoxide Drug: Metformin + Diazoxide |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 90 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2012 |
| Eligibility 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 |
| Gender | Male |
| Ages | 25 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: H de Boer, MD, PhD +31 26 3786735 HdeBoer@alysis.nl |
| Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00631033 |
|---|---|
| Other Study ID Numbers | LTC-511-230108 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Rijnstate Hospital |
| Study Sponsor | Rijnstate Hospital |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2011 |
Locations[ + expand ][ + ]
| Rijnstate Hospital | Arnhem, Netherlands Recruiting |
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