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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 April 2022 |
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Main ID: |
NCT03168009 |
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Date of registration:
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23/05/2017 |
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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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Brown Fat Activity and Bariatric Surgery
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Scientific title:
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The Role of Alternatively Activated Brown Fat in Bariatric Surgery-mediated Metabolic Improvements |
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Date of first enrolment:
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May 24, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03168009 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Florian Kiefer, 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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Medical University of Vienna |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 20 - 50 years
- Body mass index (BMI) 35 - 55kg/m2
Exclusion Criteria:
- Endocrine disease (except hyperlipidemia and substituted hypothyroidism or type 2
diabetes with fasting glucose concentrations <120mg/dl), kidney disease, inflammatory
bowel disease, autoimmune or rheumatologic diseases that require immunosuppressive
treatment, active oncologic disease, heart failure.
- Medication for any of the above mentioned conditions.
- Antibiotic treatment in the past three months
- Pregnancy
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Procedure: Bariatric Surgery
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Primary Outcome(s)
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Changes in BAT activity after bariatric surgery
[Time Frame: 4 years]
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Secondary Outcome(s)
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Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors
[Time Frame: 4 years]
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Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition
[Time Frame: 4 years]
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Secondary ID(s)
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1071/2017
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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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