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

K

Kirloskar Hospital

Status

Completed

Conditions

Diabetes

Treatments

Procedure: Ileal Interposition with Sleeve Gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Surgery group
Other group
Description:
Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy
Treatment:
Procedure: Ileal Interposition with Sleeve Gastrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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