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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00491582 |
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Date of registration:
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25/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effects of Growth Hormone (GH) on Lipid Depots
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Scientific title:
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The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00491582 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Emanuel R Christ, Prof,MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Growth hormone replacement therapy in growth hormone deficient patients only.
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Measurement of serum alphaKlothe by an ELISA
[Time Frame: 2008 - 2013]
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maximal exercise capacity
[Time Frame: 2008 - 2009]
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Secondary ID(s)
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320000-109522/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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