DZX Mediated Insulin Suppression in Obese Men

NCT ID: NCT00631033

Last Updated: 2014-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2

Diazoxide

Group Type EXPERIMENTAL

Diazoxide

Intervention Type DRUG

3

Metformin + Diazoxide

Group Type EXPERIMENTAL

Metformin + Diazoxide

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Diazoxide

Intervention Type DRUG

Metformin + Diazoxide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 30202851 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29618011 (View on PubMed)

Other Identifiers

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LTC-511-230108

Identifier Type: -

Identifier Source: org_study_id

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