Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

Study Overview
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Brief Summary
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Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. There appears to be a variable response to surgery depending on surgical and patient factors. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Detailed Description
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Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Official Title
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Long Term Effects of Bariatric Surgery on Diabetes: Comparison Between Patients With or Without Diabetes Recovery.

Conditions
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Diabetes, Bariatric Surgery, Obesity

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capacity to understand the procedures of the study. To agree voluntarily to participate of the study, signing an informed consent. Weight variance less than 5% in the last 3 months. Operative group with at least 2 year follow-up. Exclusion Criteria: History of hepatic disease like cirrhosis or chronic active hepatitis. Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men). Hepatic dysfunction: ALT and/or AST 3x above upper normal limit). Recent history of neoplasia (< 5 years). Use of oral or injectable for more than consecutive 14 days in the last three months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| 1<br>Patients with DM2 undergoing RYGB with remission of DM2 | Other: No intervention<br>* No intervention<br>|
| 2<br>Patients with DM2 undergoing RYGB without remission of DM2 | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the endogenous response of incretins, orexins and anorexins to a mixed meal test in obese patients with DM2, in patients with DM2 undergoing RYGB with remission of DM2 and in patients without remission. |  | 2 years after RYGB | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, type 2, Insulin resistance, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin, adiponectin, Cytokines, gastric bypass, Obesity