RecruitingNCT06979440

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

Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.


Sponsor

Affiliated Hospital of Nantong University

Enrollment

40 participants

Start Date

Nov 9, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the molecular and gut microbiome effects of berberine (a plant-derived compound used in traditional Chinese medicine) in people who have both type 2 diabetes and depression. Researchers want to understand how berberine may affect gut bacteria and brain chemistry. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with type 2 diabetes - You are either in the control group (diabetes without depression) or the patient group (diabetes plus depression, with a HAMD-17 score of 22 or above) - You have signed an informed consent form **You may NOT be eligible if...** - You have taken antibiotics, probiotics, or similar gut-affecting supplements in the 3 months before the study or plan to take them during it - You have a serious progressive illness such as active cancer - You have used psychotropic medications within the past month - You are pregnant or breastfeeding - You have alcohol or substance dependence Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention


Locations(1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT06979440