A clinical trial of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003059

Enrollment

Registered

2010-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes: one year follow up Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: ? age- 25-65 years. ? Body Mass Index between 25-35 kf/m2. ? currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years. ? Documented HbA1c>7.5% for at least 3 months. ? Stable weight for 3 months (+/-) ? Evidence of stable medical treatment for diabetes over the past 12 months. ? Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -

Exclusion criteria

Exclusion criteria: ? Type I diabetes/juvenile onset ? C-Peptid levels below 1.0 ng/ml ? Previous major upper abdominal surgery ? Pregnant or plans to become pregnant with in the next 12 months ? Current Malignancy ? Severe pulmonary, cardiac, or renal disease ? Eating disorders such as bulimia or binge-eating ? Severe mental health disorders such as schizophrenia and bipolar disorder ? Obesity due to other metabolic disorders ? taking appetite suppressants ? currently abusing illicit drugs, alcohol or using tobacco products ? Unable to provide informed consent ? Unwillingness or unable to comply with study procedures ? any condition that deems them unsuitable for the study in the opinion of the investigators

Design outcomes

Primary

Measure	Time frame
Remission of Type 2 Diabetes - HbA1c < 6Timepoint:	—

Secondary

Measure	Time frame
Change in requirement of hypoglycemic agents Change in body weight Change in individual components of the metabolic syndromeTimepoint:	—

Countries

India

Contacts

Public ContactDr Shabeer Ahmed

surgeonshabeer@hotmail.com08066214016

Outcome results