Correlation Between Gut Microbiota and Pancreatic Β-Cell Function in Diabetic Patients

NCT06645223 | Enrolling By Invitation

• 1 other identifier: M2024784
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The gut microbiota plays a crucial role in digestion, metabolism, nutrition, and immune regulation in the human body. In recent years, numerous studies have indicated that the gut microbiota and its metabolites are closely associated with metabolic diseases, including obesity, non-alcoholic fatty liver disease, and diabetes. China has rapidly entered an aging society, where aging is a major risk factor for abnormal glucose metabolism, manifested by decreased pancreatic function and increased insulin resistance. Concurrently, as the body ages, the composition of the gut microbiota also undergoes age-related changes, such as reduced microbial diversity, increased inter-individual variability, and a downregulation of the beneficial/harmful bacteria ratio. Therefore, direct modulation of the gut microbiota could become a potential therapeutic target for age-related metabolic diseases. Currently, some preclinical studies have transplanted fecal microbiota from young mice to aged mice to explore the improvement of age-related phenotypes, such as cognitive impairment, decreased immunity, and chronic inflammation. The regulation of the gut microbiota is susceptible to changes caused by various factors, including age, diet, antibiotics, and psychological stress. Although mice and humans share high genetic homology, differences in diet structure, body size, and metabolic processes can result in significant diversity and compositional differences in their gut microbiota. Research indicates that the core microbiota of the mouse gut consists of 4 genera, while 90% of the European population comprises 9 genera, highlighting the differences in genus or species richness between mouse and human gut microbiota. Preliminary research by our group has shown that transplanting fecal microbiota from young mice to aged mice can increase postprandial plasma insulin levels in aged mice, suggesting that the restoration of gut microbiota diversity may be involved in age-related glucose metabolism abnormalities. However, due to interspecies differences in the gut microbiota, whether the differential microbiota between elderly and young humans can improve age-related glucose metabolism abnormalities remains to be explored. Despite the abundance of human gut microbiota composition data in public databases, differences in sequencing methods, DNA extraction from specimens, and the nationality of subjects prevent standardization and integration of these data. Additionally, traditional 16s-rRNA sequencing methods lack sufficient precision in microbial classification and cannot annotate gene functions. These limitations have resulted in many studies on gut microbiota remaining at the level of exploring correlations with diseases, without establishing causality. The development of metagenomic sequencing technology can extend the definition of the human core gut microbiota to the species level and accurately annotate their gene functions. Combined with metabolomics detection, this technology can provide more comprehensive information on the dialogue between gut microbiota and the host. Therefore, this study aims to use multi-omics approaches (metagenomic sequencing and metabolomics detection) to analyze the differences in fecal microbiota and their metabolites between young and elderly populations under different glucose metabolism states. This will provide potential intervention targets for preventing age-related glucose metabolism abnormalities and offer new theoretical foundations for the molecular mechanisms of age-related metabolic diseases.

Conditions

Diabetes Mellitus; Gut Microbiota

Outcome Measures

Primary Outcomes (4)

• Metagenomic and Metabolomic Analysis of Gut Microbiota

  From September 2024 to December 2025

• Comparison of Pancreatic Beta-Cell Function Among Different Groups of Subjects

  From September 2024 to December 2025

• Comparison of Clinical Characteristics Among People with Different Glycemic Metabolic Status

  From September 2024 to December 2025

• Correlation Between Specific Bacterial Species and Pancreatic Beta-Cell Function Among Different Groups

  From September 2024 to December 2025

Study Arms (2)

Young Group

Drug: No Interventions

Elderly Group

Drug: No Interventions

Interventions

No Interventions DRUG

no interventions

Elderly Group; Young Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young and elderly subjects with different glucose metabolism states will be recruited from the community or the outpatient department of Peking University Third Hospital between September 2024 and December 2025, meeting the following criteria.

You may qualify if:

• Age: Young (18 \< age \< 45 years) and elderly (age ≥ 65 years) subjects;
• Individuals with different glucose metabolism states, including normal glucose metabolism, pre-diabetes, and diabetes, without gastrointestinal diseases or a history of gastrointestinal surgery (such as active gastrointestinal inflammation or bleeding, inflammatory bowel disease, etc.), without cognitive impairment, without tumors, and without chronic respiratory diseases (such as chronic obstructive pneumonia, asthma, etc.), and not on a special diet (e.g., vegetarians).

You may not qualify if:

• Use of antibiotics or health supplements within the last month.
• Diarrhea within the last 2 weeks: bowel movements ≥3 times/24 hours, with changes in stool consistency.
• Constipation within the last 2 weeks (based on the Rome III criteria for functional constipation).
• Acute complications of diabetes, such as diabetic ketoacidosis, within the last 3 months.
• History of gastrointestinal diseases or gastrointestinal surgery.
• Cognitive impairment.
• History of tumors.
• Special diet (e.g., vegetarians).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood、 Serum 、Feces

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yang Jin

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 16, 2024
• Study Start: September 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-09

Locations

CN (1)