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Study on biological characteristics and pathogenesis of diabetic complications integrating intestinal microbiome and metabonomics: study protocol for a group control trial

Study on biological characteristics and pathogenesis of diabetic complications integrating intestinal microbiome and metabonomics

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040870
Enrollment
Unknown
Registered
2020-12-12
Start date
2020-12-30
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

diabetic complications

Interventions

Diabetes group:nothing
Diabetic peripheral neuropathy group:Nil
Diabetic foot group:Nil

Sponsors

Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) the subjects voluntarily participate in the clinical trial and signe the written informed consent; (2) the subjects can understand the oral and / or written instructions and comply with all experimental requirements; (3) the subjects are male or female aged 18-70 years old; (4) they meet the clinical manifestations of diabetes and complications (diabetic nephropathy, diabetic peripheral neuropathy, diabetic foot disease, etc.) Performance and diagnostic criteria. Inclusion criteria of healthy volunteers: (1) subjects voluntarily participate in the clinical trial and signe written informed consent; (2) subjects can understand oral and / or written instructions and comply with all experimental requirements; (3) subjects are male or female aged 18-70 years old; (4) healthy people without diabetes history.

Exclusion criteria

Exclusion criteria: (1) patients with malignant tumors, autoimmune diseases, infectious diseases and renal insufficiency who underwent gastrointestinal surgery in the past year; (2) patients with acute metabolic disorders such as diabetic ketoacidosis in the past month; (3) pregnant and lactating women; (4) patients with severe infection in the past month; (5) alcoholism or drug abuse; (6) patients who are receiving hormone or chemotherapy and have used antibiotics within one month; (7) patients with unconsciousness, dementia and various mental diseases.

Design outcomes

Primary

MeasureTime frame
16S rRNA sequencing analysis of intestinal microorganisms;Metagenomics sequencing analysis of intestinal microflora;Non targeted metabonomics based on LC-MS;Lipidomics;Short chain fatty acids;

Secondary

MeasureTime frame
Blood routine examination;blood sugar;insulin;glycosylated hemoglobin;Tumor necrosis factor-a;Interleukin-1 ß;Interleukin-6;Plantar thermal response time;Sciatic nerve conduction velocity;24h urinary albumin;Serum creatinine;Serum urea nitrogen;Stromal cell derived factor-1;Hypoxia inducible factor-1 a;

Countries

China

Contacts

Public ContactQiyue Yang

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Ruozi0920@163.com+86 13540220206

Outcome results

None listed

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