Clinical trial NCT00834626: Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes
Official title: Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Ileal Interposition
Sleeve Gastrectomy
Type-2 Diabetes
Lead sponsor: Kirloskar Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percentage of Participants Having Remission of Type 2 Diabetes
timeFrame: One year
Secondary outcomes:
measure: Percentage of Participants Not Requiring Insulin
timeFrame: 1 year
measure: Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
timeFrame: one year
measure: Percentage of Participants Achieving Remission in Hypertension
timeFrame: 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Kirloskar Hospital
state: AP
Study officials:
affiliation: Kirloskar Hospital, Hyderabad
name: Dr Surendra Ugale, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.