Actively Recruiting
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
Led by China-Japan Friendship Hospital · Updated on 2024-10-28
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intensive weight loss treatment on renal outcomes in patients with diabetic kidney disease (DKD), particularly focusing on those with rapidly progressing diabetic nephropathy. The study aims to establish a patient group receiving such treatments and to develop a prediction model for kidney health improvements following weight loss. Participants are divided into two groups: one receiving bariatric surgery, which includes laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on beta-cell function, and another group receiving non-surgical therapy comprising diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. The study monitors outcomes at 1, 3, 6, and 12 months after intervention. During the study, participants will have regular assessments measuring total weight loss, kidney function markers such as serum creatinine and glomerular filtration rate, various blood glucose parameters, waist and hip circumference, urinary microalbumin, other urine tests, and medication status. These evaluations help track the impact of the treatments on kidney health and metabolic control over the course of one year.
CONDITIONS
Brief Title
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- Body mass index (BMI) over 25 kg/m2 or abdominal obesity (waist circumference over 90 cm for men and over 85 cm for women)
- Estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73m2 or urinary microalbumin level of 300 mg/g or higher
You will not qualify if you...
- Taking glucocorticoid medications
- Having tumors
- Having autoimmune diseases
- Serum albumin level below 25 g/L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial surgical procedure and immediate recovery period
Participants in the surgical group undergo bariatric surgery including laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function.
1 visit for surgery and immediate post-operative care
Duration - 12 months after intervention
Participants in both surgical and non-surgical groups are monitored for health outcomes including weight loss, kidney function, and blood glucose levels.
Visits at 1st, 3rd, 6th, and 12th month after intervention
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
N
Nianrong Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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