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

Not Applicable

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: growth hormone (genotropin)

• Registration Number: NCT00646815
• Lead Sponsor: University of Aarhus

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-19
• Study Start: 2008-03
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-21
• Last Update Posted: 2009-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a	growth hormone (genotropin)	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

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	before and after 3 months treatment with growth hormone

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.; 🇩🇰 Aarhus, Denmark

Medical Department M, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark