Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Kirloskar Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes

Interventions

Ileal Interposition with Sleeve GastrectomyPROCEDURE

Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kirloskar Hospital

Hyderabad, Andhra Pradesh, India

Outcomes

Primary Outcomes

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

Time frame: One year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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