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

NCT06979440 | Recruiting

• 3 other identifiers: 2024-K231-0182404740202495102
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetes-Related Complications

Keywords

Type 2 diabetes mellitus; depression; Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• The levels of 5-AVAB

  There were no additional intervention measures in this study. Faeces were collected after excretion for in vitro drug intervention experiments. The blood collection volume (5 mL) met the ISO international standard and was used to detect the 5-AVAB content in each group.

  3 years

Study Arms (2)

Control (with type 2 diabetes)

The clinical inclusion criteria are as follows: a. Age 18-65 years old; b. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment.

Other: No intervention

T2DD (with type 2 diabetes complicated with depression)

The clinical inclusion criteria are as follows: a. Age 18-65 years old; b. The T2DD patient group was diagnosed with type 2 diabetes complicated with depression (depression met the DSM-5 diagnostic criteria); c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Control (with type 2 diabetes); T2DD (with type 2 diabetes complicated with depression)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; The T2DD patient group was diagnosed with type 2 diabetes and depression, where the depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;

You may qualify if:

• Aged 18-65 years (including the critical value), regardless of gender;
• The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;
• The T2DD patient group was diagnosed with type 2 diabetes and depression, where depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;
• The subjects read and fully understood the patient instructions and signed the informed consent form.

You may not qualify if:

• Those who have not used antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. within 3 months before diagnosis, and those who do not use antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. during treatment;
• Those with progressive serious diseases (such as cancer);
• Those with severe aphasia, agnosia, and apraxia;
• Those who have used psychotropic drugs for a long time within 1 month before the study or have received new drug research in the past 3 months;
• Pregnant or breastfeeding women;
• Alcoholics or drug addicts;
• Those with poor mental condition and unable to cooperate;

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

faeces and blood

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus, Type 2; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• zhengwei zhang, PhD

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengwei Zhang, PhD

CONTACT

15701539317; zhangzhengwei95@foxmail.com

Zheng Yang, MD

CONTACT

0513-85052230; zzw3737@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: November 9, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)