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Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study

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ClinicalTrials.gov Identifier: NCT02161666
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Carsten Dirksen, Hvidovre University Hospital

Brief Summary:
To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.

Condition or disease
Obesity

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort
Patients
Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery
Controls
Age, sex and BMI-matched healthy controls



Primary Outcome Measures :
  1. Change in islet cell function from baseline (preoperatively) [ Time Frame: >24 months ]
    Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass


Secondary Outcome Measures :
  1. Change in glucose tolerance during oral glucose tolerance test [ Time Frame: >24 months ]
    Fasting, peak and nadir glucose during oral glucose tolerance test

  2. Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass [ Time Frame: >24 months ]
    Differences in arterial and venous plasma glucose during oral glucose stimulation


Biospecimen Retention:   Samples Without DNA
Plasma and serum specimens are retained


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)
Criteria

Inclusion Criteria:

  • Participation in previous study (NCT01559779)

Exclusion Criteria:

  • Pregnancy/lactation
  • Major chronic disease develop since previous examination with possible impact on outcomes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161666


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Danmark, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Carsten Dirksen, MD, PhD Hvidovre University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carsten Dirksen, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02161666    
Other Study ID Numbers: AB-CD-10-2Y
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Carsten Dirksen, Hvidovre University Hospital:
Obesity
Gastric Bypass
Bariatric Surgery
Incretin Function
Islet Function
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight