Study to assess impact of metabolic surgery on kidney disease in diabetic overweight patients

Not Applicable

• Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

• Registration Number: CTRI/2023/07/054983
• Lead Sponsor: Wockhardt Hospitals Limited, Mumbai Central

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Adult individuals 18-70 years of age

2. BMI: 27.5-32.5 kg/m2 (Class 1 obesity)

3. Known Type 2 Diabetes Mellitus > 1 year

4. Baseline HbA1c >7% on regular medical management

Exclusion Criteria

1. Type 1 Diabetes Mellitus

2. Latent Auto-immune Diabetes of Adults (LADA)

3. Maturity Onset Diabetes of Young (MODY)

4. Previously operated bariatric and metabolic surgery patients

5. Patients with history of pancreatic disease or surgery

6. Patient at very high risk of anesthetic complications

7. Known endocrinal causes of obesity like Cushingâ??s syndrome

8. Patients who lack comprehension of the bariatric surgical procedures

9. Patients with known and uncontrolled psychiatric disorders like schizophrenia and major depression

10. Patients with active substance/ drug abuse

11. Patients unwilling to give the time commitment and consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1Renal outcome measurements <br/ ><br>2 HbA1c with or without antidiabetic medicationTimepoint: At 6 months & 1 year after surgery & annually after that for 2 more years

Secondary Outcome Measures

Name	Time	Method
1.Other Micro-vascular complications(neuropathy & retinopathy) progression <br/ ><br>2.Macro-vascular outcome(Carotid intimal thickness) measurements <br/ ><br>Timepoint: At 6 months & 1 year after surgery & annually after that for 2 more years