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Completed

NCT Number: NCT00491582

The Effects of Growth Hormone (GH) on Lipid Depots

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Growth hormone replacement therapy in growth hormone deficient patients only.

Drug

Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months

Other names: Genotropin

Primary outcomes

  1. 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

Secondary outcomes

  1. maximal exercise capacity

    Time frame: 2008 - 2009

  2. Measurement of serum alphaKlothe by an ELISA

    Time frame: 2008 - 2013

    Measured in pg/mL

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Jun 26, 2007
Registry last updated
Aug 13, 2013

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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