NCT02076880

SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients

Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.

Conditions

• Severe Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Caloric restriction	Caloric restriction of 1000 kcal per day compared to the usual food intake. * usual breakfast of the patient (possibly limited in quantity) * midday and evening meals from mixed and dehydrated meals, soups with protein and dairy desserts sweetened
OTHER	No caloric restriction	No change in eating habits to patients in this arm

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-11-01
• Completion: 2017-11-01
• First posted: 2014-03-04
• Last updated: 2014-12-03

Locations

1 site across 1 country: France