Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Study Overview
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Brief Summary
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Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.

Detailed Description
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Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.

Official Title
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Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Procedure: Ileal Interposition with Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration Body Mass Index 21 - 55 kg/m^2 Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses. Gives Informed Consent for the surgery Postmeal C peptide > 1.0 ng/mL Age 25 - 75 years Stable weight for more than 3 months Exclusion Criteria: Type 1 Diabetes Postmeal C peptide < 1 ng/mL Pregnancy Significant nephropathy requiring dialysis Coexisting systemic disease Previous gastric or intestinal resection surgery Obesity due to organic illness

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery group<br>Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy | Procedure: Ileal Interposition with Sleeve Gastrectomy<br>* Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.<br>* Other names: Laparoscopic Ileal Interposition surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Having Remission of Type 2 Diabetes | The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Not Requiring Insulin | After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months | 1 year | 
| Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents | Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year | one year | 
| Percentage of Participants Achieving Remission in Hypertension | Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileal Interposition, Sleeve Gastrectomy, Type-2 Diabetes