Status:
COMPLETED
Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
University of Copenhagen
Conditions:
Type2 Diabetes
Obesity, Morbid
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operat...
Detailed Description
Design: 12 patients with type 2 diabetes will be recruited. All subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperati...
Eligibility Criteria
Inclusion
- Inclusion criteria for RYGB in Denmark (ie. BMI \> 35 in the presence of obesity related co-morbidities as type 2 diabetes)
- Type 2 diabetes
- Pre-operative: Fasting plasma glucose ≥7,0 mmol/L or 2 hour plasma glucose ≥ 11,1 mmol/L (after pausing antidiabetic medication for a minimum of 3 days)
- Written informed consent.
Exclusion
- Exclusion criteria for RYGB (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance).
- Type 2 diabetes where antidiabetic medication cannot be paused for 3 days.
- Pregnancy and breast-feeding.
- Hemoglobin \<7.0 mmol/L
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04782999
Start Date
January 1 2015
End Date
March 1 2022
Last Update
March 16 2022
Active Locations (1)
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1
Hvidovre University Hospital
Hvidovre, Denmark