Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
1 other identifier
observational
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 7, 2015
April 1, 2015
10 months
June 10, 2014
April 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in islet cell function from baseline (preoperatively)
Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass
>24 months
Secondary Outcomes (2)
Change in glucose tolerance during oral glucose tolerance test
>24 months
Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass
>24 months
Study Arms (2)
Patients
Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery
Controls
Age, sex and BMI-matched healthy controls
Eligibility Criteria
Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)
You may qualify if:
- Participation in previous study (NCT01559779)
You may not qualify if:
- Pregnancy/lactation
- Major chronic disease develop since previous examination with possible impact on outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre University Hospital
Hvidovre, Danmark, 2650, Denmark
Related Publications (1)
Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.
PMID: 27138601DERIVED
Biospecimen
Plasma and serum specimens are retained
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carsten Dirksen, MD, PhD
Hvidovre University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 12, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 7, 2015
Record last verified: 2015-04