The Effects of Growth Hormone (GH) on Lipid Depots

NCT ID: NCT00491582

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-06-30

Brief 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

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

Growth hormone replacement therapy in growth hormone deficient patients only.

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Genotropin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Emanuel Christ

Prof. Emanuel Christ, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emanuel R Christ, Prof,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 23967125 (View on PubMed)

Other Identifiers

320000-109522/1

Identifier Type: -

Identifier Source: org_study_id