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"Clinical Trial of Intestinal Surgery for Type II Diabetes"

Metabolic Surgery For The Treatment Of Type-II Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003339
Enrollment
150
Registered
2013-01-30
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

Health Condition 1: null- Type II Diabetes Mellitus

Interventions

Intervention1: Metabolic Surgery: Ileal transposition-a surgical procedure developed by a Brazilian surgeon, Dr Aureo-de Paula.The basic philosophy is that it increases the secretion of the gastro int

Sponsors

Global Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
HbA1c lessthan 6 percentTimepoint: HbA1c monitoring at 1,3,6 and 12 months from the primary procedure.

Secondary

MeasureTime frame
No Secondary OutcomeTimepoint: No Secondary Outcome

Countries

India

Contacts

Public ContactDr K S Lakshmi Kumari

Global Hospitals

lakshmi.kona@ymail.com09849713853

Outcome results

None listed

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