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Gut bugs may predict kidney decline in diabetes

NCT ID NCT07352436

Knowledge-focused Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 270 adults with diabetic kidney disease to see if gut bacteria and blood chemicals influence blood sugar swings and disease progression. Researchers will track participants over time using continuous glucose monitors and stool/blood samples. The goal is to find early warning signs and improve care, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify high-risk patients earlier and develop new strategies to manage diabetic kidney disease.
What could go wrong
This is an observational study, not a treatment trial. It may only show links, not causes, and findings might not lead to direct patient benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of adult patients diagnosed with Diabetic Kidney Disease (DKD), aged between 18 and 65 years. All participants will have a confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) in accordance with the 1999 World Health Organization diagnostic criteria, and meet the diagnostic criteria for DKD as outlined in the 2021 Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-65 years 2. Diagnosis of Diabetic Kidney Disease (DKD) 3. Type 2 Diabetes Mellitus 4. Stable Antidiabetic Regimen:The antidiabetic regimen must have been stable for at least 3 months prior to study enrollment. 5. Willingness to Provide Informed Consent: Participants must voluntarily sign an informed consent form to participate in the study. - Exclusion Criteria: 1. Acute Diabetic Complications: Participants with acute diabetic complications, such as diabetic ketoacidosis (DKA), or with primary kidney diseases like primary glomerulonephritis, nephrotic syndrome, or lupus nephritis. 2. Infection or Stress Conditions: Participants in a state of infection, trauma, or other stress conditions. 3. Pregnancy or Lactation: Women who are pregnant, breastfeeding, or planning to become pregnant in the next month. 4. Severe Dermatologic Conditions: Participants with severe dermatologic conditions, such as extensive eczema, widespread scars, tattoos, herpetic dermatitis, severe edema, or psoriasis. 5. Skin Issues with Sensor Application: Participants with severe skin issues at the site of sensor application, such as burns, injuries, sunburns, ulcers, or scars from prior surgery. 6. Coagulation or Blood Disorders: Participants with abnormal coagulation, anemia, or abnormal hematocrit. 7. Chronic Gastrointestinal Diseases or Surgery History: Participants with chronic gastrointestinal diseases or a history of gastrointestinal or biliary surgery. 8. Recent Probiotic or Antibiotic Use: Participants who have used probiotics or prebiotics, or received antibiotic treatment for more than 3 days in the past 3 months, or have consumed yogurt or yogurt-containing foods/beverages in the past week.

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.