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CompletedNCT00491582Updated Aug 13, 2013

The Effects of Growth Hormone (GH) on Lipid Depots

An interventional study of Growth hormone replacement therapy in growth hormone deficient patients only. in Growth Hormone Deficiency, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-13.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Growth Hormone Deficiency
03

In context

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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.

Interventions

  • DrugGrowth 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

    Also known as: Genotropin

06

What researchers measure

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

    Measured in pg/mL

    Time frame: 2008 - 2013

07

Study locations

1 site
  • Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital
    Bern, 3010, Switzerland
08

References and documents

Publications

  • Egger A, Kreis R, Allemann S, Stettler C, Diem P, Buehler T, Boesch C, Christ ER. The effect of aerobic exercise on intrahepatocellular and intramyocellular lipids in healthy subjects. PLoS One. 2013 Aug 14;8(8):e70865. doi: 10.1371/journal.pone.0070865. eCollection 2013. PubMed 23967125 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00491582
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation
Responsible party
Emanuel Christ (Prof. Emanuel Christ, MD, PhD, Insel Gruppe AG, University Hospital Bern) — Principal investigator
First posted
Jun 26, 2007
Start date
Jul 2007
Primary completion
Jul 2009
Completion
Jun 2013
Last update
Aug 13, 2013

Study contacts

Emanuel R Christ, Prof,MD,PhD
principal investigator · Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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