The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient

Study Overview
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Brief Summary
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Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery. The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively. Aims & methodology: Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function. Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative. To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared

Official Title
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Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass

Conditions
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Type 2 Diabetes, Morbid Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male subjects aged 18 to 65 BMI > 35 kg/m2 Subject is capable and willing to give informed consent. In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of 199112. Patient suffers from type 2 diabetes necessitating insulin therapy. Subject is a non-smoker for at least 6 months prior to study start. Female patients of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the screening visit. Patients using hormonal contraception should use a barrier method in addition from screening visit until their next normal period following the end of the study. Female patients of non-child bearing potential defined as: Post-menopausal females, being amenorrhoeic for at least 1 year Pre-menopausal females with a documented hysterectomy or bilateral oophorectomy. Exclusion Criteria: Female patient is pregnant or breastfeeding. BMI < 35 kg/m2 Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor…) Patient suffers from type 1 diabetes, MODY or LADA Patient has undergone previous surgical procedure for weight loss Patient is considered ASA 4 or more according to the ASA physical status classification system of the American Society of Anesthesiologists. Patient suffers from liver cirrhosis Patient uses steroids Patient uses cyclosporin Recent (<30 days) or simultaneous participation in another clinical trial. Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PMSF<br>type 2 diabetes patient receiving a protein sparing diet | |
| sleeve gastrectomy<br>type 2 diabetes patient receiving a gastric bypass | |
| RYGBP<br>type 2 diabetes patient receiving a gastric bypass | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity and beta cell function | insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in plasma levels of gut hormones and inflammation markers |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, gastric bypass, sleeve gastrectomy, clamp study, weight loss surgery