Obesity Clinical Trial
Official title:
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
Verified date | February 2008 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Dutch Health Care Inspectorate |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | body weight | |||
Primary | abdominal circumference | |||
Primary | body composition measured by Dual Energy X-ray Absorptiometry | |||
Primary | glucose tolerance |
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