A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy (EBSDKD)

Establish a cohort of diabetic kidney disease(DKD) patients with intensive weight loss treatment to evaluate the impact of intensive weight loss treatment on the renal prognosis of DKD and construct a prediction model for the improvement of renal outcomes after weight loss.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Nephropathy; Bariatric Surgeries
• Intervention / Treatment: Procedure: Bariatric surgery; Other: Non-surgical therapy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nianrong Zhang; Phone Number: +86 188 1048 8650; Email: znrsd@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with DKD treated with intensive weight loss or traditional treatment

Description

Inclusion Criteria:

• Age 18 to 65 years old;

  • BMI>25Kg/m2 or abdominal obesity (i.e. waist circumference>90cm for men and>85cm for women);

    • eGFR<30ml/min/1.73m2 or urinary microalbumin≥300mg/g, eGFR<60ml/min/1.73m2.

Exclusion Criteria:

• Patients who are taking glucocorticoids;

  • Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin<25g/L.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-surgical group	Other: Non-surgical therapy; Diet management，exercise，metformin，GLP-1 receptor agonists and other drugs which can lose weight.
Surgical group	Procedure: Bariatric surgery; Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function; Other: Non-surgical therapy; Diet management，exercise，metformin，GLP-1 receptor agonists and other drugs which can lose weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total weight loss	1st, 3rd, 6th and 12th month after intervention, respectively.

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum creatinine	1st, 3rd, 6th and 12th month after intervention, respectively.
Glomerular filtration rate	1st, 3rd, 6th and 12th month after intervention, respectively.
Fasting blood glucose	1st, 3rd, 6th and 12th month after intervention, respectively.
Average blood glucose from continuous glucose monitoring	1st, 3rd, 6th and 12th month after intervention, respectively.
Postprandial 2-hour blood glucose	1st, 3rd, 6th and 12th month after intervention, respectively.
HbA1c	1st, 3rd, 6th and 12th month after intervention, respectively.
Waist circumference and hip circumference	1st, 3rd, 6th and 12th month after intervention, respectively.
Urinary microalbumin and other Urinalysis indexes	1st, 3rd, 6th and 12th month after intervention, respectively.
Medication status	1st, 3rd, 6th and 12th month after intervention, respectively.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Hua Meng, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: EBSDKD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No