- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631033
DZX Mediated Insulin Suppression in Obese Men
November 5, 2014 updated by: Rijnstate Hospital
Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Arnhem, Netherlands
- Rijnstate Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo
|
|
Experimental: 2
Diazoxide
|
|
Experimental: 3
Metformin + Diazoxide
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4014-4022. doi: 10.1210/jc.2018-01147.
- Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. Effects of Diazoxide-Mediated Insulin Suppression on Glucose and Lipid Metabolism in Nondiabetic Obese Men. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2346-2353. doi: 10.1210/jc.2018-00161.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 27, 2008
First Submitted That Met QC Criteria
February 27, 2008
First Posted (Estimate)
March 7, 2008
Study Record Updates
Last Update Posted (Estimate)
November 6, 2014
Last Update Submitted That Met QC Criteria
November 5, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTC-511-230108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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