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

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ClinicalTrials.gov Identifier: NCT00646815
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : October 22, 2009
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: growth hormone (genotropin) Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009


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.



Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: before and after 3 months treatment with growth hormone ]

Secondary Outcome Measures :
  1. substrate metabolism [ Time Frame: before and after 3 months of growth hormone treatment ]
  2. intrahepatic lipid content [ Time Frame: before and after 3 months of growth hormone treatment ]
  3. intramyocellular lipid content [ Time Frame: before and after 3 months of growth hormone treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646815


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

Additional Information:
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
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: October 22, 2009
Last Verified: October 2009

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:
Hypersensitivity
Insulin Resistance
Endocrine System Diseases
Dwarfism, Pituitary
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
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
Insulin, Globin Zinc
Insulin
Hormones
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists