Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (IISG)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00834626 |
Recruitment Status
:
Completed
First Posted
: February 3, 2009
Results First Posted
: August 31, 2012
Last Update Posted
: September 6, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes | Procedure: Ileal Interposition with Sleeve Gastrectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834626
India | |
Kirloskar Hospital | |
Hyderabad, AP, India, 500063 |
Principal Investigator: | Dr Surendra Ugale, MS | Kirloskar Hospital, Hyderabad |
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 |
First Posted: | February 3, 2009 Key Record Dates |
Results First Posted: | August 31, 2012 |
Last Update Posted: | September 6, 2012 |
Last Verified: | August 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 |