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

NCT ID: NCT02076880

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm with caloric restriction

Patients in this arm will have, during 7 days before surgery, a caloric restriction of 1000 kcal per day compared to the usual food intake. They will be hospitalized during this period.

Intervention: caloric restriction

Group Type: EXPERIMENTAL

Caloric restriction

Intervention Type: OTHER

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

Arm without caloric restriction

Patients in this arm will not have a caloric restriction before surgery.

Intervention: No caloric restriction

Group Type: EXPERIMENTAL

No caloric restriction

Intervention Type: OTHER

No change in eating habits to patients in this arm

Interventions

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

Intervention Type: OTHER

No caloric restriction

No change in eating habits to patients in this arm

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• written informed consent
• Age between 18-65 years (inclusive)
• Men or women receiving effective contraception, postmenopausal or sterile
• type 2 diabetes treated with no drugs or oral anti-diabetic agents metformin, sulfonylurea or glinides
• Body mass index 35 kg / m² or above
• eligible to bariatric surgery according to HAS criteria

Exclusion Criteria

• Treatment of diabetes with GLP1 analogues, DPP-IV (dipeptidyl-peptidase IV) or insulin
• Treatment with drugs that modify glucose homeostasis: glucocorticoids, anorexigens, antihistaminics, psychotropic drugs especially serotonergic antidepressants (except for the occasional use of a hypnotic or anxiolytic), atropine, laxatives, thyroid hormones (with the exception of a substitution dose ensuring a stable euthyroid at baseline), beta blockers, diuretics
• Pregnancy, intention of being pregnant, breastfeeding.
• Inability to understand the nature and aims of the study or to communicate with the investigator- High probability of non
• compliance with the protocol
• Simultaneous participation in another trial
• No affiliation to the French social security
• Loss of personal capacity resulting in state protection
• Deprivation of liberty by judicial or administrative decision

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence GALTIER, MD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence GALTIER, MD

Role: CONTACT

f-galtier@chu-montpellier.fr

Eric RENARD, PU-PH

Role: CONTACT

e-renard@chu-montpellier.fr

Facility Contacts

GALTIER Florence

Role: primary

f-galtier@chu-montpellier.fr

Other Identifiers

2012-A00962-41

Identifier Type: OTHER

Identifier Source: secondary_id

9016

Identifier Type: -

Identifier Source: org_study_id