Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
NCT ID: NCT00151684
Last Updated: 2008-02-29
Study Results
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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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2004-11-30
Brief Summary
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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.
Detailed Description
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Study design:
This study is an open-labelled, non-randomized, phase IIa study.
Treatment:
During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.
Endpoints, monthly determined:
* body weight
* abdominal circumference
* body composition measured by Dual Energy X-ray Absorptiometry
* glucose tolerance
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Diazoxide
Eligibility Criteria
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Inclusion Criteria
* fasting C-peptide plasma level \> 1.0 nmol/L
* HbA1c of 6.0% or lower
* Absence of comorbidity
* Absence of medication use
Exclusion Criteria
* Liverenzymes \> 2 times the upper normal limit
* Gout
* Alcohol use \> 2 units/day
* Illicit drug use
* Quit smoking less than 6 months ago
30 Years
50 Years
MALE
Yes
Sponsors
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Rijnstate Hospital
OTHER
Principal Investigators
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Hans de Boer, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital, Arnhem, The Netherlands
Locations
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Rijnstate Hospital
Arnhem, , Netherlands
Countries
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References
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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.
Other Identifiers
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LTC-268-060504
Identifier Type: -
Identifier Source: org_study_id