Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
NCT ID: NCT00646815
Last Updated: 2009-10-22
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
NA
24 participants
INTERVENTIONAL
2008-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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a
the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency
growth hormone (genotropin)
Dosage regulation will follow the local recommendations of GHD treatment
Control
Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI.
No interventions assigned to this group
Interventions
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growth hormone (genotropin)
Dosage regulation will follow the local recommendations of GHD treatment
Eligibility Criteria
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Inclusion Criteria
* Must be of legal age and competent
* Age: \>18 and \<60 years old
* Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study
* Written informed consent
* Must be of legal age and competent
Exclusion Criteria
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* BMI \>30
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.
Controls are matched on age, gender and BMI
* Alcohol consumption \>21 units per week
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial
18 Years
60 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark
Principal Investigators
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Jens OL Jorgensen, Professor MD
Role: PRINCIPAL_INVESTIGATOR
Medical Department M, Aarhus University Hospital, Aarhus, Denmark
Locations
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Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
Aarhus, Aarhus, Denmark
Medical Department M, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Related Links
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Louise Møller
Danish Data Protection Agency
Other Identifiers
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LM2008
Identifier Type: -
Identifier Source: org_study_id
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