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Pathogenesis studies of type 2 diabetic kidney disease based on metabonomics and intestinal flora

Pathogenesis studies of type 2 diabetic kidney disease based on metabonomics and intestinal flora

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054649
Enrollment
Unknown
Registered
2021-12-23
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Diabetic kidney disease

Interventions

T2DKD group:None
Healthy group:None

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: T2DKD group: 1. Aged 30 to 75 years, gender is not limited; 2. Meet the 1999 World Health Organization (WHO) diagnostic criteria for T2DM: fasting blood glucose >126 mg/dL (or >7.0 mmol/L), 2 h postprandial blood glucose >200 mg/dL (or 11.1 mmol/L) ), or OGTT test 2-hour blood glucose > 200 mg/dL (11.1 mmol/L), random blood glucose >= 200 mg/dL (11.1 mmol/L); 3. Meet the diagnostic criteria for DKD in the 2014 Expert Consensus on the Prevention and Treatment of DKD: Urine microalbumin/creatinine ratio (UACR) > 30 mg/g; 4. According to the diagnostic criteria for DKD in the 2014 Expert Consensus on the Prevention and Treatment of DKD: glomerular filtration rate (eGFR) 15 mL/min/1.73m^2; 5. The blood pressure is stable below 160/90 mmHg; 6. Informed consent, voluntary experiment. The process of obtaining informed consent conforms to GCP regulations. T2DM group: 1. Aged 30 to 75 years, gender is not limited; 2. Meet the 1999 World Health Organization (WHO) diagnostic criteria for T2DM: fasting blood glucose >126 mg/dL (or >7.0 mmol/L), 2 h postprandial blood glucose >200 mg/dL (or 11.1 mmol/L) ), or OGTT test 2 h blood glucose > 200 mg/dL (11.1 mmol/L), random blood glucose >= 200 mg/dL (11.1 mmol/L); 3. UACR60 mL/min/1.73m^2; 5. The blood pressure is stable below 160/90 mmHg; 6. Informed consent, voluntary experiment. The process of obtaining informed consent conforms to GCP regulations. Chronic kidney disease group: 1. Aged 30 to 75 years, gender is not limited; 2.UACR>=30 mg/g; 3. eGFR >15 mL/min/1.73m^2; 4. Fasting blood glucose 60 mL/min/1.73m^2; 5. The blood pressure is stable below 160/90 mmHg; 6. No confirmed acute or chronic diseases; 7. Informed consent, voluntary experiment. The process of obtaining informed consent conforms to GCP regulations.

Exclusion criteria

Exclusion criteria: T2DKD group 1. Type 1.1 DM patients; 2. Other secondary nephritis not caused by DM; 3. DM ketoacidosis, hyperglycemic hyperosmolar syndrome, infection, severe DM foot gangrene occurred within one month; 4. Renovascular hypertension; 5. Combined with serious diseases of the heart, brain, liver and hematopoietic system, or other serious diseases that affect their survival; 6. Pregnant or lactating women; 7. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 8. Those who have used antibiotics in the past 3 months. T2DM group 1. Type 1.1 DM patients; 2. Various types of kidney diseases; 3. DM ketoacidosis, hyperglycemic hyperosmolar syndrome, infection, severe DM foot gangrene occurred within one month; 4. Renovascular hypertension; 5. Combined with serious diseases of the heart, brain, liver and hematopoietic system, or other serious diseases that affect their survival; 6. Pregnant or lactating women; 7. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 8. Those who have used antibiotics in the past 3 months. Chronic kidney disease group 1. DM patients; 2. Renovascular hypertension; 3. Combined with serious diseases of the heart, brain, liver and hematopoietic system, or other serious diseases that affect their survival; 4. Pregnant or lactating women; 5. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 6. Those who have used antibiotics in the past 3 months. Healthy group 1. Blood sugar and renal function do not meet normal values; 2. Combined with serious diseases of the heart, brain, liver and hematopoietic system, or other serious diseases that affect their survival; 3. Pregnant or lactating women; 4. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 5. Those who have used antibiotics in the past 3 months.

Design outcomes

Primary

MeasureTime frame
serum metabolomics;fecal metabolomics;intestinal flora;

Secondary

MeasureTime frame
urine metabolomics;

Countries

China

Contacts

Public ContactLi Changyin

Affiliated Hospital of Nanjing University of Chinese Medicine

13913959331@126.com+86 13913959331

Outcome results

None listed

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