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

NCT02076880 | Unknown

• 2 other identifiers: 90162012-A00962-41
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Type 2 diabetes; Obesity; Sleeve gastrectomy; Insulin; GLP-1

Outcome Measures

Primary Outcomes (1)

• Change of area under the curve of post prandial glycemia

  Baseline to day 7 after surgery

Secondary Outcomes (1)

• Change in insulin sensitivity, Change in insulin secretion, Change in incretins

  Blood samples at D-15, D-7 before surgery, D7, D80, D170, D350 after surgery

Study Arms (2)

Arm with caloric restriction

EXPERIMENTAL

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

Other: Caloric restriction

Arm without caloric restriction

EXPERIMENTAL

Patients in this arm will not have a caloric restriction before surgery. Intervention: No caloric restriction

Other: No caloric restriction

Interventions

Caloric restriction 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 with caloric restriction

No caloric restriction OTHER

No change in eating habits to patients in this arm

Arm without caloric restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2; Obesity; Insulin Resistance

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Florence GALTIER, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence GALTIER, MD

CONTACT

f-galtier@chu-montpellier.fr

Eric RENARD, PU-PH

CONTACT

e-renard@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: March 4, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: December 3, 2014

Record last verified: 2013-09

Locations

FR (1)