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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00646815
First received: February 19, 2008
Last updated: October 21, 2009
Last verified: October 2009
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Resource links provided by NLM:

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
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.

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

No publications provided

Responsible Party: Louise Møller, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark
ClinicalTrials.gov Identifier: NCT00646815     History of Changes
Other Study ID Numbers: LM2008
Study First Received: February 19, 2008
Last Updated: October 21, 2009
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, Pituitary
Endocrine System Diseases
Insulin Resistance
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Insulin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013