Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: growth hormone (genotropin) (Drug)
Phase: N/A
Status: Recruiting
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
Overall contact:
Jens OL Jorgensen, Professor, Phone: +0045 8949 2019, Email: joj@ki.au.dk
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: Basic Science, Open Label, Parallel Assignment
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
Jens OL Jorgensen, Professor, Phone: +0045 8949 2019, Email: joj@ki.au.dk
Medical Department M, Aarhus University Hospital, Aarhus 8000, Denmark; Recruiting
Jens OL Jorgensen, Email: joj@ki.au.dk
Louise Moller, Ext: l, Email: louisem@dadlnet.dk
Louise Moller, Sub-Investigator
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark., Aarhus 8000, Denmark; Not yet recruiting
Louise Moller, MD, Phone: 8949 2171, Email: lmll@ki.au.dk
Louise Moller, MD, Sub-Investigator
Additional Information
Central Denmark Region Committee on Biomedical Research Ethics Jens Otto Lunde Jorgensen Louise Møller Danish Data Protection Agency
Starting date: March 2008
Ending date: May 2009
Last updated: October 8, 2008
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