The Effects of Growth Hormone (GH) on Lipid Depots

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Emanuel Christ, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00491582
First received: June 25, 2007
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity.

In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max.

Finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated.

Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)Growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability.

3)Free fatty availability during exercise will be reduced in growth hormone deficient patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency


Condition Intervention
Growth Hormone Deficiency
Drug: Growth hormone replacement therapy in growth hormone deficient patients only.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Determination of visceral fat mass by MRI,Determination of IMCL and IHCL by MR Spectroscopy, Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp [ Time Frame: 2008 - 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maximal exercise capacity [ Time Frame: 2008 - 2009 ] [ Designated as safety issue: No ]
  • Measurement of serum alphaKlothe by an ELISA [ Time Frame: 2008 - 2013 ] [ Designated as safety issue: No ]
    Measured in pg/mL


Enrollment: 34
Study Start Date: July 2007
Study Completion Date: June 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Athletes, controls, patients
Sedentary controls: age, BMI, Gender and waist matched (to the growth hormone deficient patients) healthy control subjects Endurance trained athletes: minimal >50 mlO2/KG body weight
Drug: Growth hormone replacement therapy in growth hormone deficient patients only.
Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months
Other Name: Genotropin

Detailed Description:

Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed.

Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass by MR-imaging.

Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical investigations are performed in adult growth hormone (GH) deficient patients before and after six months GH replacement therapy, in sedentary matched control subjects and in endurance trained athletes.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female patients with proven GH-deficiency defined as a peak GH of less than 3mU/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed.
  • Ability to perform an exercise test on a treadmill or a walking band.
  • Willingness to participate in the study and to give written informed consent.

Exclusion Criteria:

Active neoplasia

  • Severe cardiovascular disease (unstable coronary heart disease, heart failure NYHA III-IV)
  • Type 2 Diabetes mellitus
  • Haemophilia or other coagulation disorder
  • Inability to exercise
  • Contraindications to exposure to a 3-T magnetic field (Pace-Makers, osteosynthetic material)
  • Pregnant women
  • Women in childbearing age unless on a continuous contraceptive therapy or surgically sterilised.
  • Abnormal liver or renal function (Creatinine >130mmol/L, normal reference 45-93mmol/L; ASAT and ALAT > 3 times the upper reference limit).
  • Major depression, psychosis and other severe personality disorders
  • Excessive alcohol consumption (>60g/d) or drug-abuse
  • Refusal to give written consent
  • Patients, who are not suitable for the study according to the study physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491582

Locations
Switzerland
Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
Principal Investigator: Emanuel R Christ, Prof,MD,PhD Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emanuel Christ, Prof. Emanuel Christ, MD, PhD, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00491582     History of Changes
Other Study ID Numbers: 320000-109522/1
Study First Received: June 25, 2007
Last Updated: August 12, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Dwarfism, Pituitary
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
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014