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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00646815
Other study ID # LM2008
Secondary ID
Status Completed
Phase N/A
First received February 19, 2008
Last updated October 21, 2009
Start date March 2008
Est. completion date September 2009

Study information

Verified date October 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
growth hormone (genotropin)
Dosage regulation will follow the local recommendations of GHD treatment

Locations

Country Name City State
Denmark Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark. Aarhus
Denmark Medical Department M, Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary insulin sensitivity before and after 3 months treatment with growth hormone No
Secondary substrate metabolism before and after 3 months of growth hormone treatment No
Secondary intrahepatic lipid content before and after 3 months of growth hormone treatment No
Secondary intramyocellular lipid content before and after 3 months of growth hormone treatment No
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