N/A
N=30
Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00834626 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants Having Remission of Type 2 Diabetes — 76.66 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ileal Interposition with Sleeve Gastrectomy (Procedure)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Kirloskar Hospital
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Having Remission of Type 2 Diabetes |
76.66 | — |
| SECONDARY Percentage of Participants Not Requiring Insulin |
90 | — |
| SECONDARY Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents |
93 | — |
| SECONDARY Percentage of Participants Achieving Remission in Hypertension |
90 | — |
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 Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00834626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.