Clinical Trial of Intestinal Surgery for Type II Diabetes
- Conditions
- Health Condition 1: null- Type II Diabetes Mellitus
- Registration Number
- CTRI/2013/01/003339
- Lead Sponsor
- Global Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Male and female between 18 and 65 years.
BMI 25.1 - 34.9.
Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
Diagnosis of T2DM for at least 3 years.
Patient has been under routine care of the study physician or another physician that can supply a reliable medical record for at least 3 years.
HbA1c >/ 7.5 documented for at least 3 months.
Stable weight (nor significant weight change ( >3%) over the 3 months prior to enrollment.
Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
Prior abdominal surgery, except laparoscopic cholecystectomy.
Taking appetite suppressant.
Severe eating disorders.
Severe pulmonary, renal or cardiac disease.
Obese due to a clinically diagnosed endocrine disorder.
Subjects with impaired liver function.
History of peptic ulcer disease.
History of malignant disease.
Pregnant or planning on pregnancy while enrolled in study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method