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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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8 August 2016 |
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Main ID: |
NCT02665715 |
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Date of registration:
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25/01/2016 |
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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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Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
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Scientific title:
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Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet? |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02665715 |
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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: Crossover 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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Denmark
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Contacts
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Name:
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Sten Madsbad, MD, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Name:
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Kirstine Bojsen-Moller, MD, Postdoc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RYGB operated patients more than 12 month after operation
- Stable in weight for at least 3 months (+/- 3 kg)
- Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or
with continuous glucose monitoring
Exclusion Criteria:
- Fasting plasma glucose concentration > 7mmol/L
- Critical illness
- Hgb < 6.5 mM
- Pregnancy or breastfeeding
Age minimum:
25 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bariatric Surgery (Gastric Bypass)
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Intervention(s)
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Other: Low carbohydrate meals
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Other: Standard carbohydrate meals
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Primary Outcome(s)
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Nadir plasma glucose
[Time Frame: 0-240 min, 240-480 min]
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Secondary Outcome(s)
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Time to nadir glucose
[Time Frame: 0-240 min, 240-480 min]
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Peak plasma glucose
[Time Frame: 0-240 min, 240-480 min]
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Time to peak glucose
[Time Frame: 0-240 min, 240-480 min]
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Postprandial incremental GLP-1 area
[Time Frame: 0-240 min, 240-480 min]
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Time below basline glucose concentrations
[Time Frame: 0-480 min]
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Postprandial decremental glucose area
[Time Frame: 0-240 min, 240-480 min]
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Glycemic excursions
[Time Frame: 0-480 min]
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Postprandial incremental insulin area
[Time Frame: 0-240 min, 240-480 min]
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Postprandial incremental glucose area
[Time Frame: 0-240 min, 240-480 min]
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Secondary ID(s)
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DK-REAKTIV-15
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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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