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Completed

NCT Number: NCT00646815

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

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).

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Digestive System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Hypopituitarism Hypothalamic Diseases Insulin Resistance Liver Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Growth hormone (Genotropin)

Drug

Dosage regulation will follow the local recommendations of GHD treatment

Primary outcomes

  1. insulin sensitivity

    Time frame: before and after 3 months treatment with growth hormone

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 31, 2008
Registry last updated
Oct 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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