Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06979440

Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression

Led by Affiliated Hospital of Nantong University · Updated on 2025-05-28

40

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. The preliminary experiments identified 5-AVAB, a gut microbiota-derived metabolite, as a potential novel biomarker for T2DD progression. Given the absence of existing research in this area, it warrants in-depth investigation. The investigators plan to collect fecal and serum samples from participants with type 2 diabetes and those with T2DD to quantify 5-AVAB levels, as well as conduct in vitro gut microbiota culturing and sequencing studies.

CONDITIONS

Official Title

Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-65 years, any gender
  • Diagnosed with type 2 diabetes and no history of mental disorders for the control group
  • Diagnosed with type 2 diabetes and depression meeting DSM-5 criteria with HAMD-17 score 2 or higher for the T2DD group
  • Able to understand study information and provide informed consent
Not Eligible

You will not qualify if you...

  • Not meeting inclusion criteria
  • Used antibiotics, prebiotics, probiotics, or enteral nutrition drugs within 3 months before diagnosis or during treatment
  • Having progressive serious diseases like cancer
  • Having severe speech, recognition, or movement disorders
  • Using psychotropic drugs long-term within 1 month before study or involved in new drug research in past 3 months
  • Pregnant or breastfeeding
  • Alcohol or drug addiction
  • Poor mental condition preventing cooperation
  • Deemed unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 226001

Actively Recruiting

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Research Team

Z

Zhengwei Zhang, PhD

CONTACT

Z

Zheng Yang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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