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A clinical study to evaluate effect of surgery for control of Type2 diabetes in overweight individuals

Not Applicable
Registration Number
CTRI/2008/091/000206
Lead Sponsor
Self
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

1.Diagnosed Type 2 Diabetes for 1-5 years
2. Poorly controlled blood sugar despite standard of care as demonstrated by HbA1C 8-11 & 3 office visits
3. BMI between 23.0 and 35
4. Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
5. Age between 25 and 65(both men & women will be included)
6. Able to provide Informed Consent.
7. Able to comply with follow-up procedures.

Exclusion Criteria

1. Previous history of major abdominal surgery which may lead to a hostile abdomen.
2. Pregnancy
3. Patients who have an incurable malignant or debilitating disease.
4.Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart
5.Diagnosed severe eating disorder
6.Untreated endocrine disorder
7.Active peptic ulcer
8.Untreated H. pylori
9.Cognitive Impairment
10.Diabetic autonomic neuropathy
11.Symptomatic gastroparesis

Study & Design

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