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

Nanjing First Hospital，Nanjing Medical University

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jianhua Jianhua, Doctor; Phone Number: +861895167011 +862552887091; Email: majianhua196503@126.com
• Study Contact Backup: Name: Jianhua Jianhua; Phone Number: +862552887091; Email: majianhua196503@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Jianhua Ma, Profseeor; Phone Number: +8618951670116; Email: majianhua196503@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

T2DM patients who are not treated with any hypoglycemic drugs visited in the Department of Endocrinology at the Nanjing First Hospital from January 2023 to March 2023 were enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
T2DM group; Collect stool and blood samples，No drugs use.
Control group; Collect stool and blood samples，No drugs use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal 16S rRNA gene sequencing	Fecal 16S rRNA gene sequencing results of two group	Day one

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Jianhua Ma, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Estimate): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KY20230116-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No