Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: growth hormone (genotropin) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Jens OL Jorgensen, Professor MD, Principal Investigator, Affiliation: Medical Department M, Aarhus University Hospital, Aarhus, Denmark
Summary
The purpose of this study is to further characterize the treatment related changes in
insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in
patients with growth hormone deficiency (GHD).
Clinical Details
Official title: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: insulin sensitivity
Secondary outcome: substrate metabolismintrahepatic lipid content intramyocellular lipid content
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent
- 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
Exclusion Criteria:
- Alcohol consumption >21 units per week
- 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
Inclusion Criteria:
- Written informed consent
- Must be of legal age and competent
Exclusion Criteria:
- 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
Locations and Contacts
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark., Aarhus 8000, Denmark
Medical Department M, Aarhus University Hospital, Aarhus 8000, Denmark
Additional Information
Central Denmark Region Committee on Biomedical Research Ethics Danish Data Protection Agency
Starting date: March 2008
Last updated: October 21, 2009
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