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

NCT06661174 | Recruiting

• 1 other identifier: EBSDKD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgeries; Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• Total weight loss

  1st, 3rd, 6th and 12th month after intervention, respectively.

Secondary Outcomes (9)

• 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.

Study Arms (2)

Surgical group

Procedure: Bariatric surgery; Other: Non-surgical therapy

Non-surgical group

Other: Non-surgical therapy

Interventions

Bariatric surgery PROCEDURE

Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function

Surgical group

Non-surgical therapy OTHER

Diet management，exercise，metformin，GLP-1 receptor agonists and other drugs which can lose weight.

Non-surgical group; Surgical group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who are taking glucocorticoids;
• Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin\<25g/L.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hua Meng

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nianrong Zhang

CONTACT

+86 188 1048 8650; znrsd@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: October 28, 2024
• Study Start: October 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CN (1)