DZX Mediated Insulin Suppression in Obese Men

Rijnstate Hospital

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Diazoxide; Drug: Placebo; Drug: Metformin + Diazoxide

Study type: Interventional

Funder types: Other

Identifiers

NCT00631033

LTC-511-230108

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Male

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

Diazoxide

Treatment:

Drug: Diazoxide

3

Experimental group

Description:

Metformin + Diazoxide

Treatment:

Drug: Metformin + Diazoxide