Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-03-01
2020-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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10 Roux-en-Y Gastric Bypass patients
4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
Low GI mealtest
Meal with low glycaemic index (GI) is consumed over 20 min
Low GI mealtest and subsequent exercise
Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
High GI mealtest
Meal with high glycaemic index (GI) is consumed over 20 min
High GI mealtest and subsequent exercise
Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
10 control subjects
4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
Low GI mealtest
Meal with low glycaemic index (GI) is consumed over 20 min
Low GI mealtest and subsequent exercise
Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
High GI mealtest
Meal with high glycaemic index (GI) is consumed over 20 min
High GI mealtest and subsequent exercise
Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
Interventions
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Low GI mealtest
Meal with low glycaemic index (GI) is consumed over 20 min
Low GI mealtest and subsequent exercise
Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
High GI mealtest
Meal with high glycaemic index (GI) is consumed over 20 min
High GI mealtest and subsequent exercise
Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
Eligibility Criteria
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Inclusion Criteria
* Achieved \> 50% Excess BMI Loss
* Weight stability (no fluctuations over ± 5 kg the last 3 months)
* HBA1c \< 48 mmol/mol before and after surgery without the use of anti-diabetic medication
* The participant must be able to ingest the meals
* Matched with the RYGB patients on gender, age (± 5 years), menopausal state (pre- versus post-menopausal) and BMI (± 3 points).
* Weight stable ( ± 5 kg during 3 months)
* HBA1c \< 48 mmol/mol
Exclusion Criteria
* Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
* Dysregulated thyroid gland affection
* The use of medication which affects heart frequency (i.e. Beta-blockers)
* Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).
Control group:
* Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.
20 Years
75 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Kirstine Nyvold Bojsen-Moeller
OTHER
Responsible Party
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Kirstine Nyvold Bojsen-Moeller
Kirstine Nyvold Bojsen-Moeller
Principal Investigators
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Kirstine N Bojsen-Moller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology, Hvidovre Hospital
Locations
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Department of Endocrinology, Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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ExRYGB
Identifier Type: -
Identifier Source: org_study_id
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