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Personalized Microecological Comprehensive Diagnosis and Treatment Technology for Diabetic Nephropathy

Personalized Microecological Comprehensive Diagnosis and Treatment Technology for Diabetic Nephropathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079695
Enrollment
Unknown
Registered
2024-01-10
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic kidney disease

Interventions

High-dietary fiber bagged intervention group:Give patients high dietary fiber for 0-28 days, 29-56 days, do not take products, receive routine diabetic nephropathy diet health guidance, and carry out
High dietary fiber bagged candidate group:On days 1-28, routine diabetic nephropathy diet is prescribed as prescribed, and on days 29-56, high-dietary fiber bags are packed for 28 days as prescribed.
FGT transplant group:Transplant healthy patients with cornerstone functional groups transplanted to patients and given high dietary fiber
M group (Phase 1-3a):None
S group (Phase 3b-5):None
Healthy control group:None

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for diabetic nephropathy; (2) glycated hemoglobin (HbA1c) = 11%; (3) 18 years old< age < 79 years old (age is calculated according to the difference between the date of the screening survey and the date of birth); (4) not currently participating in other research projects; (5) Have good memory and activity ability; (6) mental health, life can take care of themselves; (7) Sign informed consent; (8) Those who are better at compliance have an urgent desire to change their physical condition and fully understand the "enterogenic theory of chronic diseases". Healthy control group: healthy people matched with diabetes nephropathy group in age, place of origin, amount of exercise and age.

Exclusion criteria

Exclusion criteria: (1) After drug treatment, blood pressure is still = 180/110mmHg; (2) Consider kidney injury for non-diabetic renal disease: patients with a history of diabetes mellitus < a large amount of proteinuria or renal insufficiency within 5 years, a large amount of proteinuria or nephrotic syndrome in the short term, "active" glomerular hematuria suggested by urine sediment, rapid decline in eGFR of unknown cause or eGFR decrease of more than 30% within 3 months after ACEI/ARB treatment; (3) Suffering from infectious diseases such as HIV, hepatitis, tuberculosis, etc.; (4) Suffering from autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.; (5) Patients with severe organic diseases, malignant tumor diseases or undergoing radiotherapy, chemotherapy and immunotherapy; (6) Those who have undergone gastrointestinal surgery (including bariatric surgery); (7) Have used antibiotics in the past 1 month and have lasted for 3 days or more; (8) pregnant and lactating women; (9) hypersensitivity or intolerance to any ingredient in high dietary fiber bags (containing corn husk, wheat, sorghum, oats, inulin and 30g of dietary fiber); (10) Alcoholism (drinking more than 5 times a week, with an average of 2 taels of liquor or half a kilogram of rice wine or more than 5 bottles of beer each time); (11) Those with physical disabilities, serious mental disorders, or other reasons caused by the inability to take care of themselves, recall and answer questions clearly; (12) There is no guarantee of sufficient time to participate in this project.

Design outcomes

Primary

MeasureTime frame
ACR;eGFR;

Secondary

MeasureTime frame
Microbiota structure and function;Renal function;Cardiac function;HbA1c;OGTT;blood lipids;PTH;electrolyte;Serum albumin;Bone markers;Bone mineral density;Blood pressure;weight;BMI;DEXA;

Countries

China

Contacts

Public ContactHuijuan Yuan

Henan Provincial People Hospital

hjyuan@zzu.edu.cn+86 135 1389 1997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026