NCT01993511

Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. However the mechanisms for this improvement remain uncertain. The aim of this study is to investigate the changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB using oral and intravenous test.

Detailed description

Investigators plan to study 24 obese patients already enrolled for Roux-en-y gastric bypass surgery (RYGB). 8 with type 2 diabetes (DM2), 8 with impaired glucose tolerance (IGT) and 8 with normal glucose tolerance (NGT) before, within the first week and 3 month after RYGB using a liquid mixed meal test (MMT) and an insulin modified frequently sampled intravenous glucose tolerance test (IM-FSIGT). Furthermore, an oral glucose tolerance test (OGTT) will be performed before and after 3 months. Blood will be sampled in fasting and during the tests measuring plasma glucose, insulin and C-peptid (OGTT, MMT and IM-FSIGT) and GLP-1, glucagon, GIP and GLP-2 (MMT). Beta-cell function will be assessed from the MMT (insulinogenic index - IGI), OGTT (IGI) and the IM-FSIGT (Acute insulin response, AIR) in order to examine whether changes in beta-cell function after RYGB depend on an oral stimulus. Insulin sensitivity will be assessed in fasting (HOMA-IR), during the IM-FSIGT (minimal model: Si) and from MMT/OGTT (Matsuda index). Insulin clearance/hepatic extraction of insulin will be assessed in fasting and during the intravenous and oral test.

Conditions

• Type 2 Diabetes
• Obesity

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-11-25
• Last updated: 2013-11-25

Locations

1 site across 1 country: Denmark