Effect of Gastric Bypass Surgery on Uncontrolled Type-2 Diabetes in Patients with BMI 23 32.5

One Anastomosis Gastric Bypass Surgery (OAGB) for Uncontrolled Type-2 Diabetes Mellitus in Patients with Body Mass Index between 23 and 32.5 kg/m : A Pre- and Post-Quasi-interventional Clinical Trial - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106448

Enrollment

Registered

2026-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: One Anastomosis Gastric Bypass: One Anastomosis Gastric Bypass is a laparoscopic surgical procedure in which a gastric pouch will be created using linear staplers guided by a 38 F bougi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 75 years, of both gender 2. BMI between 23 to 32.5 kg per meter square 3.Type-2 Diabetes Mellitus (T2DM) confirmed based on ADA criteria. 4. HbA1c level more than 7.5% despite 2 years of intensive lifestyle and medical therapy (three or more Oral Hypoglycemic Agents with or without GLP-1 receptor agonists or Insulin) 5. T2DM with at least one documented early or advanced sign of end-organ damage (Albuminuria uACR more than 30 mg per gram, Diabetic Retinopathy- mild to severe non-proliferative, Macrovascular atherosclerosis, documented CAD, prior CVA or TIA, or PAD), irrespective of HbA1c. 6. Informed Consent and Compliance

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus or Positive Anti glutamic acid decarboxylase antibodies. 2. Post-prandial plasma C-peptide levels less than 0.9 ng per mL 3. Cushings Syndrome, Pituitary Failure, or use of systemic glucocorticoids. 4. Active Inflammatory Bowel Disease 5. Chronic Liver Disease defined by Child-Pugh Class B or C or a Model for End-Stage Liver Disease score more than 15 6. Prior Gastric Surgery 7. Active Substance/Alcohol Dependence 8. Uncontrolled or uncorrectable cardiopulmonary illness 9. Uncontrolled Psychiatric Illness and Non-Compliance 10. Unrealistic Expectations of the surgical outcome 11. Unwillingness or Inability to Comply 12. Pregnancy, lactation, or planning to become pregnant within 12 months post-surgery

Design outcomes

Primary

Measure	Time frame
To determine the effect of One Anastomosis Gastric Bypass surgery in achieving Remission of Diabetes MellitusTimepoint: 12 months	—

Secondary

Measure	Time frame
1. Assessment of Excess weight loss 2. Change in Glycemic Control Indicators HbA1c, FBS, PPBS, HOMA-IR 3. Change in Anthropometric Measures 4. Resolution/Improvement of Associated Comorbidities Hypertension, Dyslipidemia 5. Assessment of changes in Diabetes Complications Diabetic Nephropathy Markers, Diabetic Neuropathy Status, Diabetic Retinopathy Status 6. Incidence and Severity of Post-operative Complications. 7. Incidence of Nutritional DeficienciesTimepoint: 12 months	—

Measure

Time frame

1. Assessment of Excess weight loss 2. Change in Glycemic Control Indicators HbA1c, FBS, PPBS, HOMA-IR 3. Change in Anthropometric Measures 4. Resolution/Improvement of Associated Comorbidities Hypertension, Dyslipidemia 5. Assessment of changes in Diabetes Complications Diabetic Nephropathy Markers, Diabetic Neuropathy Status, Diabetic Retinopathy Status 6. Incidence and Severity of Post-operative Complications. 7. Incidence of Nutritional DeficienciesTimepoint: 12 months

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Countries

India

Contacts

Public ContactNemi Chandra

All India Institute of Medical Sciences New Delhi

nemicj06@gmail.com8904941806

Outcome results

None listed

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