Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Obesity, Morbid; Type2 Diabetes

• Registration Number: NCT04782999
• Lead Sponsor: Hvidovre University Hospital

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-operative type 2 diabetes.

Primary hypotheses:

* After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect).

* After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively.

* After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

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 postoperatively:

* Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be performed before and 3 months post-surgery.

* Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2022-01
• Status Verified: 2022-03
• Study Completion: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Insulinotropic effects of GLP-1 and GIP	Change from before to 1 week and 3 months after RYGB	Insulin secretion during steady state of all hyperglycemic clamps
Insulin secretion during oral stimulation	Change from before to 3 month after RYGB	AUC of C-peptide during oral glucose tolerance test
Insulin secretion during iv stimulation	Change from before to 1 week and 3 months after RYGB	Insulin secretion during hyperglycemic clamp with saline infusion and during argininine iv stimulation test

Secondary Outcome Measures

Name	Time	Method
Alpha cell function	Change from before to after 1 week and 3 months after RYGB	Glucagon secretion during hyperglycemic clamps

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark