Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes - Full Text View

Purpose

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	Intervention
Diabetes	Procedure: Ileal Interposition with Sleeve Gastrectomy


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes

Further study details as provided by Kirloskar Hospital:

Primary Outcome Measures:

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:

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
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
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


Enrollment:	30
Study Start Date:	January 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834626

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

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
Study First Received:	February 1, 2009
Results First Received:	February 3, 2011
Last Updated:	August 30, 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

ClinicalTrials.gov processed this record on May 25, 2017

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