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Note: This record shows only 22 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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00459940
Date of registration: 12/04/2007
Prospective Registration: No
Primary sponsor: University of Aarhus
Public title: The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients
Scientific title: "Can Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists?"
Date of first enrolment: September 2004
Target sample size: 20
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00459940
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Jens OL Jorgensen, MD
Address: 
Telephone:
Email:
Affiliation:  University of Aarhus
Key inclusion & exclusion criteria

Inclusion Criteria:

- Growth hormone replaced (minimum 6 months) growth hormone deficient men

- Age over 18 years

Exclusion Criteria:

- Ischemic coronary disease, defined by EF<0.6, former myocardial infarction, angina
pectoris or actual treatment of cardiac insufficiency

- Actual or former malignancy, except intracranial neoplasia that caused the
participants pituitary disease, provided that there was clinical evidence for
permanent remission

- Blood donation within 6 months

- Excessive alcohol consumption

- Known allergic reaction from contents of test drug

- Radioactive radiation exposure in terms of treatment or study enrollment within one
year

- Liver insufficiency

- Insulin treatment



Age minimum: 19 Years
Age maximum: 71 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency
Intervention(s)
Drug: Pioglitazone
Primary Outcome(s)
Circulating FFA level
FFA turnover
Lipid oxidation
Secondary Outcome(s)
Secondary ID(s)
20030288
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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