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

Study Overview
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Brief Summary
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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).

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

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: growth hormone (genotropin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a<br>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 | Drug: growth hormone (genotropin)<br>* Dosage regulation will follow the local recommendations of GHD treatment<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  | before and after 3 months treatment with growth hormone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substrate metabolism |  | before and after 3 months of growth hormone treatment | 
| intrahepatic lipid content |  | before and after 3 months of growth hormone treatment | 
| intramyocellular lipid content |  | before and after 3 months of growth hormone treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin sensitivity, substrate metabolism, fatty liver, intramyocellular lipids, growth hormone deficiency, Growth hormone deficiency (Adult)