Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Diabetes Clinical Trial

— IISG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834626
• Other study ID #: KH-001
• Status: Completed
• Phase: N/A
• First received: February 1, 2009
• Last updated: August 30, 2012
• Start date: January 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Kirloskar Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Ileal Interposition with Sleeve Gastrectomy
Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.

Locations

Country	Name	City	State
India	Kirloskar Hospital	Hyderabad	AP

Sponsors (1)

Lead Sponsor	Collaborator
Kirloskar Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No