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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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16 December 2017 |
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Main ID: |
NCT02419092 |
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Date of registration:
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30/03/2015 |
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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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Obstructive Sleep Apnea-induced Changes in Adipose and Liver Tissue and Effects of Massive Weight Loss on Inflammation
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Scientific title:
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Investigation of Inflammation Induced by Obstructive Sleep Apnea: Effects of Continuous Positive Airway Pressure (CPAP), Massive Weight Loss and the Bioactive Compound Resveratrol |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02419092 |
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Study type:
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Observational |
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Study design:
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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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Steen B Pedersen, MD,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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Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female/Male
- Legally competent (habil)
- 25-65 years old
- BMI > 35 and fulfill criteria for bariatric surgery in Denmark
- Written informed consent
Exclusion Criteria:
- Current treatment with CPAP
- Permanent treatment with glucocorticoids, NSAID or sleeping pills (otherwise
discontinued for 1 week prior to inclusion)
- Severe heart, liver, kidney or lung disease
- Type 1 diabetes
- Work in transportation-related industry
- Pregnancy
- Substance abuse problem
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea
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Obesity
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Primary Outcome(s)
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Metabolic changes in adipose and liver tissue induced by OSA. Obese subjects with OSA will be compared to obese subjects without OSA.
[Time Frame: Biopsies and blood samples obtained in relation to bariatric surgery]
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Secondary Outcome(s)
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Effect of bariatric surgery on the severity of OSA.
[Time Frame: Evaluated at baseline, 4 weeks post-bariatric surgery and 6 months post-bariatric surgery]
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Effect of bariatric surgery on adipose tissue inflammation and systemic inflammation.
[Time Frame: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery.]
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Effect of bariatric surgery on insulin sensitivity.
[Time Frame: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery]
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Secondary ID(s)
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LIRMOI-5-OSA
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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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