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Completed

NCT Number: NCT00834626

Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirloskar Hospital

Hyderabad, Andhra Pradesh, 500063, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ileal Interposition with Sleeve Gastrectomy

Procedure

Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.

Other names: Laparoscopic Ileal Interposition surgery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kirloskar Hospital

Other

Registry information

Official study title

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

Acronym: IISG

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 3, 2009
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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