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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: |
NCT03514576 |
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Date of registration:
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19/04/2018 |
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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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Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
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Scientific title:
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Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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5 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03514576 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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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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Caroline C Øhrstrøm, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medicine, Zealand University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who
have previously completed the study 'Treatment of hypoglycemia following gastric
bypass surgery' (HypoGB2015)
- Hemoglobin > 7,3 mmol/L
- Negative human chorionic gonadotropin (hCG) urine test
- Females of reproductive age: use of safe contraception
Exclusion Criteria:
- Treatment for cardiovascular disease
- Treatment with antipsychotic medication
- Treatment for thyroid disease
- Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
- Prior allergic reactions to the study medicine
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hypoglycemia, Reactive
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Intervention(s)
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Drug: Pasireotide 0.3 MG/ML
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Diagnostic Test: Meal tolerance test (MTT)
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Primary Outcome(s)
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Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Secondary Outcome(s)
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Plasma GLP-1 levels
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Serum insulin levels
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Heart rate
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Blood pressure
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Plasma glucagon levels
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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Serum C-peptide levels
[Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
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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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