NCT00151684

Brief Summary

The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

First QC Date

September 8, 2005

Last Update Submit

February 27, 2008

Conditions

ObesityHyperinsulinism

Keywords

ObesityHyperinsulinismDiazoxide

Outcome Measures

Primary Outcomes (4)

  • body weight

  • abdominal circumference

  • body composition measured by Dual Energy X-ray Absorptiometry

  • glucose tolerance

Interventions

DiazoxideDRUG

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • fasting glucose \< 7.0 mmol/L
  • fasting C-peptide plasma level \> 1.0 nmol/L
  • HbA1c of 6.0% or lower
  • Absence of comorbidity
  • Absence of medication use

You may not qualify if:

  • Plasma Creatinine \> 120 micromol/L
  • Liverenzymes \> 2 times the upper normal limit
  • Gout
  • Alcohol use \> 2 units/day
  • Illicit drug use
  • Quit 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 (1)

  • Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45. doi: 10.1111/j.1463-1326.2004.00449.x.

    PMID: 15811140BACKGROUND

MeSH Terms

Conditions

ObesityHyperinsulinism

Interventions

Diazoxide

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 Compounds

Study Officials

  • Hans de Boer, MD PhD

    Rijnstate Hospital, Arnhem, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

November 1, 2004

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

NL(1)