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

Phase 3
Registration Number
CTRI/2010/091/003059
Lead Sponsor
Dr Shabeer Ahmed
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
20
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

?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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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