Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00646815
• Date of registration: 19/02/2008
• Prospective Registration: Yes
• Primary sponsor: University of Aarhus
• Public title: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
• Scientific title: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
• Date of first enrolment: March 2008
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00646815
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Jens OL Jorgensen, Professor MD
• Affiliation: Medical Department M, Aarhus University Hospital, Aarhus, Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: growth hormone (genotropin)

Primary Outcome(s)

insulin sensitivity [Time Frame: before and after 3 months treatment with growth hormone]

Secondary Outcome(s)

intramyocellular lipid content [Time Frame: before and after 3 months of growth hormone treatment]

substrate metabolism [Time Frame: before and after 3 months of growth hormone treatment]

intrahepatic lipid content [Time Frame: before and after 3 months of growth hormone treatment]

Secondary ID(s)

LM2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital