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Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men - Article


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Diazoxide Injection

Hyperstat IV 




Clinical Trial: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

This study is currently recruiting patients.
Verified by Rijnstate Hospital September 2005

Sponsored by: Rijnstate Hospital
Information provided by: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00151684

Purpose

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.

Condition Intervention Phase
Obesity
Hyperinsulinism
 Drug: Diazoxide
Phase II

MedlinePlus related topics:  Metabolic Disorders;   Obesity

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II

Further Study Details: 
Primary Outcomes: - body weight; - abdominal circumference; - body composition measured by Dual Energy X-ray Absorptiometry; - glucose tolerance
Expected Total Enrollment:  25

Study start: November 2004

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.

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

Eligibility

Ages Eligible for Study:  30 Years   -   50 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00151684

Hans de Boer, MD PhD      0031-26-3788888    HdeBoer@alysis.nl

Netherlands
      Rijnstate Hospital, ARNHEM,  Netherlands; Recruiting
Hans de Boer, MD PhD  0031-26-3788888    HdeBoer@alysis.nl 
Gerben AJ van Boekel, MD  0031-26-3788888    GvanBoekel@alysis.nl 
Gerben AJ van Boekel, MD,  Sub-Investigator

Study chairs or principal investigators

Hans de Boer, MD PhD,  Principal Investigator,  Rijnstate Hospital, Arnhem, The Netherlands   

More Information

Publications

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.

Study ID Numbers:  LTC-268-060504
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00151684
Health Authority: Netherlands: Dutch Health Care Inspectorate
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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December 3, 2009



Page Updated: June 1, 2005
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