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The Alteration of Gut Microbiota and Analysis of Related Factors in Newly Diagnosed Type 2 Diabetes Patients

Nanjing First Hospital,Nanjing Medical University

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05752851
Enrollment
60
Registered
2023-03-03
Start date
2023-02-01
Completion date
2023-07-31
Last updated
2023-03-03

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

Conditions

Type 2 Diabetes

Brief summary

This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.

Detailed description

Previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (IBD), colorectal cancer (CRC), Alzheimer's disease (AD) and cardiovascular diseases. In recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance,pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of T2DM. At present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. Therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed T2DM and the control group by using 16S rRNA gene sequencing analysis technology, so as to increase the understanding of the possible relationship between T2DM and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1)18-65 years old 2)have no history of diabetes 3)fasting blood glucose \<5.6 mmol/L 4) HbA1c\<6.0%.

Exclusion criteria

1)BMI≥28kg/m2 2) People with type 1 diabetes, special type diabetes and pregnancy diabetes 3) Use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) Having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) History of abdominal surgery or gastrointestinal surgery 6) Suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) Combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.

Design outcomes

Primary

MeasureTime frameDescription
Fecal 16S rRNA gene sequencingDay oneFecal 16S rRNA gene sequencing results of two group

Countries

China

Contacts

Primary ContactJianhua Jianhua, Doctor
majianhua196503@126.com+862552887091
Backup ContactJianhua Jianhua
majianhua196503@126.com+862552887091

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026