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

This study has been completed.

First Received: February 19, 2008 Last Updated: October 21, 2009 History of Changes

Sponsor:	University of Aarhus
Collaborators:	Aarhus University Hospital MR Research Centre, Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00646815

Purpose

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	Intervention
Growth Hormone Deficiency	Drug: growth hormone (genotropin)

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Insulin Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

insulin sensitivity [ Time Frame: before and after 3 months treatment with growth hormone ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

substrate metabolism [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]
intrahepatic lipid content [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]
intramyocellular lipid content [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	March 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
a: Experimental 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
Control: No Intervention 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646815

Locations

Denmark
Medical Department M, Aarhus University Hospital
Aarhus, Denmark, 8000
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

MR Research Centre, Aarhus University Hospital

Investigators

Principal Investigator:

Jens OL Jorgensen, Professor MD

Medical Department M, Aarhus University Hospital, Aarhus, Denmark

More Information

Additional Information:

Central Denmark Region Committee on Biomedical Research Ethics This link exits the ClinicalTrials.gov site

Jens Otto Lunde Jorgensen This link exits the ClinicalTrials.gov site

Louise Møller This link exits the ClinicalTrials.gov site

Danish Data Protection Agency This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark ( Louise Møller )
Study ID Numbers:	LM2008
Study First Received:	February 19, 2008
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00646815 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

insulin sensitivity
substrate metabolism
fatty liver

intramyocellular lipids
growth hormone deficiency
Growth hormone deficiency (Adult)

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary

Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Insulin
Hypoglycemic Agents
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 04, 2010