Status:
COMPLETED
Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes
Lead Sponsor:
Kirloskar Hospital
Conditions:
Diabetes
Eligibility:
All Genders
25-75 years
Phase:
NA
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 B...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00834626
Start Date
January 1 2008
End Date
May 1 2011
Last Update
September 6 2012
Active Locations (1)
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1
Kirloskar Hospital
Hyderabad, Andhra Pradesh, India, 500063