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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00151684 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
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Scientific title:
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Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00151684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Hans de Boer, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rijnstate Hospital, Arnhem, The Netherlands |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hyperinsulinism
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Obesity
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Intervention(s)
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Drug: Diazoxide
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Primary Outcome(s)
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abdominal circumference
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body composition measured by Dual Energy X-ray Absorptiometry
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body weight
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glucose tolerance
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Secondary ID(s)
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LTC-268-060504
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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