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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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12 December 2020 |
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Main ID: |
NCT02782208 |
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Date of registration:
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18/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lipolytic Effects of GH in Hypopituitary Patients in Vivo
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Scientific title:
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Lipolytic Effects of GH in Hypopituitary Patients in Vivo: Molecular Mechanisms and Temporal Patterns. |
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Date of first enrolment:
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February 10, 2016 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02782208 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jens Otto L Jørgensen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Aarhus |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hypopituitary patients with documented GH-deficiency
Exclusion Criteria:
- other significant disease
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Glucose Metabolism Disorders
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Brain Diseases
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Pituitary Diseases
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Endocrine System Diseases
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Hypopituitarism
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Metabolic Diseases
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Intervention(s)
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Drug: Placebo
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Drug: GH substitution
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Drug: Acipimox
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Other: GH pause
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Primary Outcome(s)
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Lipolytic activity measured as area under the curve (AUC) for FFA (free fatty acid) before and during clamp-conditions.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Insulin sensitivity as measured by M value and GIR (glucose infusion rate)
[Time Frame: 6 months]
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PDH (pyruvate dehydrogenase) activity in skeletal muscle measured by an PDH activity assay
[Time Frame: 1 year]
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Substrate metabolism as measured by indirect calorimetry, tritiated glucose and circulating hormones and metabolites
[Time Frame: 1 year]
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GH signaling proteins and gene targets in adipose and skeletal muscle tissues measured by western blotting and qPCR
[Time Frame: 1,5 years]
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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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