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