Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (IISG)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes	Procedure: Ileal Interposition with Sleeve Gastrectomy	Not Applicable

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
Study Start Date :	January 2008
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2011

Arms and Interventions

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Arm	Intervention/treatment
Surgery group; Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy	Procedure: Ileal Interposition with Sleeve Gastrectomy; Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.; Other Name: Laparoscopic Ileal Interposition surgery

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

India
Kirloskar Hospital
Hyderabad, AP, India, 500063

Sponsors and Collaborators

Kirloskar Hospital

Investigators

Principal Investigator:	Dr Surendra Ugale, MS	Kirloskar Hospital, Hyderabad

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Kirloskar Hospital
ClinicalTrials.gov Identifier:	NCT00834626 History of Changes
Other Study ID Numbers:	KH-001
First Posted:	February 3, 2009
Results First Posted:	August 31, 2012
Last Update Posted:	September 6, 2012
Last Verified:	August 2012

Keywords provided by Kirloskar Hospital:

Ileal Interposition; Sleeve Gastrectomy; Type-2 Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases