Bariatric SurgeriesEBSDKDNCT06661174
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
An observational study of Bariatric Surgeries and Diabetic Nephropathy, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgeries, Diabetic Nephropathy
- What is being tested?
- Bariatric surgery and Non-surgical therapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with DKD treated with intensive weight loss or traditional treatment
Who may be able to join
- 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.
Who cannot join
- Patients who are taking glucocorticoids;
- Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin<25g/L.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
About this study
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
- Being tested
- Bariatric surgery, Non-surgical therapy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function
Non-surgical therapyOther
Diet management，exercise，metformin，GLP-1 receptor agonists and other drugs which can lose weight.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Not described Receives: Procedure: Bariatric surgery; Other: Non-surgical therapy | |
| Non-surgical group | Not described Receives: Other: Non-surgical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Secondary outcomes (9)
Serum creatinine
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Glomerular filtration rate
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Fasting blood glucose
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Average blood glucose from continuous glucose monitoring
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Postprandial 2-hour blood glucose
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
HbA1c
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Waist circumference and hip circumference
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Urinary microalbumin and other Urinalysis indexes
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Medication status
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Oct 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
- Investigators
- Hua Meng, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661174
- Sponsor's protocol ID
- EBSDKD
- Acronym
- EBSDKD
- Status last verified
- Oct 2024
- First submitted
- 22 May 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06661174
- Acronym / sponsor ID
- EBSDKD / EBSDKD
- Conditions
- Bariatric Surgeries, Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: Bariatric surgery, Other: Non-surgical therapy |
| Non-surgical group | – | Other: Non-surgical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with DKD treated with intensive weight loss or traditional treatment
Key inclusion criteria (3 listed)
- Age 18 to 65 years old;
Key exclusion criteria (2 listed)
- Patients who are taking glucocorticoids;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryLaparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function | Procedure or surgery | Surgical group |
| Non-surgical therapyDiet management，exercise，metformin，GLP-1 receptor agonists and other drugs which can lose weight. | Other | Non-surgical group, Surgical group |
Primary outcome
Total weight loss
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Related trials for Bariatric Surgeries
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Recruiting
HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
RecruitingObservational study
15-years Outcomes of Sleeve Gastrectomy on Weight Loss
Bariatric Surgery, Sleeve Gastrectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Meng principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgeries and Diabetic Nephropathy, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nianrong Zhang (+86 188 1048 8650, znrsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weight loss (time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.