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

University of Aarhus

Status: Completed

Conditions: Growth Hormone Deficiency

Treatments: Drug: growth hormone (genotropin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00646815

LM2008

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

a

Experimental group

Description:

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

Treatment:

Drug: growth hormone (genotropin)

Control

No Intervention group

Description:

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.