The Effects of Growth Hormone (GH) on Lipid Depots

NCT00491582 | Completed

• 1 other identifier: 320000-109522/1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Growth Hormone Deficiency

Outcome Measures

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

  2008 - 2009

Secondary Outcomes (2)

• maximal exercise capacity

  2008 - 2009

• Measurement of serum alphaKlothe by an ELISA

  2008 - 2013

Study Arms (1)

Athletes, controls, patients

NO INTERVENTION

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

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

Also known as: Genotropin

Athletes, controls, patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23967125 DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Emanuel R Christ, Prof,MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Emanuel Christ, MD, PhD

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: June 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

CH (1)