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Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

NCT ID: NCT00834626

Last Updated: 2012-09-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-05-31

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.

Conditions

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Diabetes

Keywords

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Ileal Interposition Sleeve Gastrectomy Type-2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery group

Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy

Group Type OTHER

Ileal Interposition with Sleeve Gastrectomy

Intervention Type PROCEDURE

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

Interventions

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Ileal Interposition with Sleeve Gastrectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic Ileal Interposition surgery

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirloskar Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Surendra Ugale, MS

Role: PRINCIPAL_INVESTIGATOR

Kirloskar Hospital, Hyderabad

Locations

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Kirloskar Hospital

Hyderabad, Andhra Pradesh, India

Site Status

Countries

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India

References

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Kumar KV, Ugale S, Gupta N, Naik V, Kumar P, Bhaskar P, Modi KD. Ileal interposition with sleeve gastrectomy for control of type 2 diabetes. Diabetes Technol Ther. 2009 Dec;11(12):785-9. doi: 10.1089/dia.2009.0070.

Reference Type BACKGROUND
PMID: 20001679 (View on PubMed)

Ugale S, Gupta N, Modi KD, Kota SK, Satwalekar V, Naik V, Swapna M, Kumar KH. Prediction of remission after metabolic surgery using a novel scoring system in type 2 diabetes - a retrospective cohort study. J Diabetes Metab Disord. 2014 Aug 22;13(1):89. doi: 10.1186/s40200-014-0089-y. eCollection 2014.

Reference Type DERIVED
PMID: 25426451 (View on PubMed)

Other Identifiers

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KH-001

Identifier Type: -

Identifier Source: org_study_id