The Effects of Growth Hormone (GH) on Lipid Depots

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Brief Title

The Effects of Growth Hormone (GH) on Lipid Depots

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 maximal exercise capacity

Condition

Growth Hormone Deficiency

Intervention

Growth hormone replacement therapy in growth hormone deficient patients only.

Study Arms / Comparison Groups

 Athletes, controls, patients
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

34

Start Date

July 2007

Completion Date

June 2013

Primary Completion Date

July 2009

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Emanuel R Christ, Prof,MD,PhD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT00491582

Organization ID

320000-109522/1


Responsible Party

Principal Investigator

Study Sponsor

University Hospital Inselspital, Berne

Collaborators

 Swiss National Science Foundation

Study Sponsor

Emanuel R Christ, Prof,MD,PhD, Principal Investigator, Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne


Verification Date

August 2013