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CompletedNCT00631033Updated Nov 6, 2014

DZX Mediated Insulin Suppression in Obese Men

A Phase 2 interventional study of Placebo and Diazoxide in Obesity, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to male participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-11-06.

Sponsored by Rijnstate Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • obesity
  • hyperinsulinism
  • diazoxide
  • metformin
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 51 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.

Browse Rijnstate Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Placebo comparator
    1

    Placebo

    Drug: Placebo

  • Experimental
    2

    Diazoxide

    Drug: Diazoxide

  • Experimental
    3

    Metformin + Diazoxide

    Drug: Metformin + Diazoxide

Interventions

06

Study locations

1 site
  • Rijnstate Hospital
    Arnhem, Netherlands
07

References and documents

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. PubMed 30202851 ↗
  • 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. PubMed 29618011 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2008
First posted
Mar 7, 2008
Start
Jul 2008
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Nov 6, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00631033
Lead sponsor
Rijnstate Hospital
First posted
Mar 7, 2008
Start date
Jul 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Nov 6, 2014
View the source record on ClinicalTrials.gov ↗

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