NCT00631033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2008

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

3.4 years

First QC Date

February 27, 2008

Last Update Submit

November 5, 2014

Conditions

Obesity

Keywords

obesityhyperinsulinismdiazoxidemetformin

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

Diazoxide

Drug: Diazoxide

3

EXPERIMENTAL

Metformin + Diazoxide

Drug: Metformin + Diazoxide

Interventions

PlaceboDRUG
1
DiazoxideDRUG
2
Metformin + DiazoxideDRUG
3

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 30202851DERIVED

  • 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.

    PMID: 29618011DERIVED

MeSH Terms

Conditions

ObesityHyperinsulinism

Interventions

DiazoxideMetformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

BenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

NL(1)