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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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4 July 2016 |
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Main ID: |
NCT02336659 |
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Date of registration:
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08/01/2015 |
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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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Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
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Scientific title:
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Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02336659 |
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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: Single Blind (Subject), 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 Madbad, MD, DMSc |
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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:
- Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose
<7.0 mM and HbA1c < 48 mmol/mol 3 month after RYGB.
Exclusion Criteria:
- Fasting plasma glucose >7.0 mM and HbA1c > 48 mmol/mol 3 month after RYGB. Hemoglobin
<6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for
sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic
complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis.
Bad compliance.
- Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with
vomiting, diarrhea or severe abdominal pain after food intake).
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Obesity
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Intervention(s)
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Drug: exendin 9-39
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Other: Placebo
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Drug: sitagliptin
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Primary Outcome(s)
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Ad libitum food intake (changes in food intake)
[Time Frame: 3-12 month after RYGB]
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Secondary Outcome(s)
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Glucose metabolism (iAUC of glucose and c-pep after a meal)
[Time Frame: 3-12 month after RYGB]
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Appetite measurement (VAS-scores)
[Time Frame: 3-12 month after RYGB]
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Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
[Time Frame: 3-12 month after RYGB]
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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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