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Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (IISG)
This study has been completed.
Sponsor:
Kirloskar Hospital
Information provided by (Responsible Party):
Kirloskar Hospital
ClinicalTrials.gov Identifier:
NCT00834626
First received: February 1, 2009
Last updated: August 30, 2012
Last verified: August 2012
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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: None (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00834626
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 September 20, 2017