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NCT Number: NCT06661174

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

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.

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Key information

Conditions

Bariatric Surgeries Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

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

Non-surgical therapy

Other

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

Primary outcomes

  1. Total weight loss

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

Secondary outcomes

  1. Serum creatinine

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

  2. Glomerular filtration rate

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

  3. Fasting blood glucose

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

  4. Average blood glucose from continuous glucose monitoring

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

  5. Postprandial 2-hour blood glucose

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

  6. HbA1c

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

  7. Waist circumference and hip circumference

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

  8. Urinary microalbumin and other Urinalysis indexes

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

  9. Medication status

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nianrong Zhang

CONTACT

[email protected]

+86 188 1048 8650

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Acronym: EBSDKD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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