NCT04782999

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes
• Obesity, Morbid

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral Glucose Tolerance Test	Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.
DIAGNOSTIC_TEST	Hyperglycemic clamp with infusion of saline, GLP-1 or GIP	Blood glucose kept at 15 mmol/L via iv 20% glucose infusions. Primed co-infusion of either: * Saline * GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min) * GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min).

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2021-03-04
• Last updated: 2022-03-16

Locations

1 site across 1 country: Denmark