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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00646815

Collaborator

Aarhus University Hospital (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency	Drug: growth hormone (genotropin)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: a 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) Dosage regulation will follow the local recommendations of GHD treatment
No Intervention: Control 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.

Arm

Intervention/Treatment

Experimental: a

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)

Dosage regulation will follow the local recommendations of GHD treatment

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.	Aarhus		Denmark	8000
2	Medical Department M, Aarhus University Hospital	Aarhus		Denmark	8000