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

A clinical trial of surgical treatment of Type2 Diabetes in non morbidly obese patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000206
Enrollment
100
Registered
2008-11-17
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: Sleeve Gastrectomy with Ileal Transposition Surgery: Post op follow up of 1 year to assess glycemic control Control Intervention1: Nil: Nil

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Reduction or Stoppage of anti-diabetic medicationTimepoint: 3 months & 6 months

Secondary

MeasureTime frame
Glycemic Control with HbA1C < 6.5Timepoint: 6 months & 12 months

Countries

India

Contacts

Public ContactDr Madhu Goel

Honarary Associate Professor of Surgery, Grant Medical College

obesityclinic@rediffmail.com0229820170763

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026