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
36 participants
INTERVENTIONAL
2019-07-01
2021-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Interventions
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Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Eligibility Criteria
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Inclusion Criteria
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion
* Age \> 18 years
* no former RYGB- or SG operation
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1 mmol/l and no history of diabetes
Exclusion Criteria
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations
Matching between groups
* Age
* Sex
* BMI at inclusion and for surgery groups also pre-surgery BMI
18 Years
ALL
Yes
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Morten Gadegaard Hindsø, MD
Principal Investigator
Principal Investigators
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Kirstine N Bojsen-Møller, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Endocrinology, Hvidovre Hospital, Denmark
Morten G Hindsø, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Endocrinology, Hvidovre Hospital, Denmark
Locations
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Department of Endocrinology
Hvidovre, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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MH-INKA-BAR-19
Identifier Type: -
Identifier Source: org_study_id
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