Recruiting NCT06661174
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric surgery, Non-surgical therapy.
- Who it may be relevant to
- Registry conditions: Bariatric Surgeries, Diabetic Nephropathy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Total weight loss [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
Secondary outcome measures (9)
- Serum creatinine [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Glomerular filtration rate [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Fasting blood glucose [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Average blood glucose from continuous glucose monitoring [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Postprandial 2-hour blood glucose [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- HbA1c [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Waist circumference and hip circumference [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Urinary microalbumin and other Urinalysis indexes [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
- Medication status [Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06661174 · EBSDKD