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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00962-41 | Other Identifier | ID-RCB - ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Arm without caloric restriction | Experimental | Patients in this arm will not have a caloric restriction before surgery. Intervention: No caloric restriction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric restriction | Other | Caloric restriction of 1000 kcal per day compared to the usual food intake.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of area under the curve of post prandial glycemia | Baseline to day 7 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence GALTIER, MD | Contact | f-galtier@chu-montpellier.fr | ||
| Eric RENARD, PU-PH | Contact | e-renard@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence GALTIER, MD | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| No caloric restriction | Other | No change in eating habits to patients in this arm |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |