NCT06979440Recruiting
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.
Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 13 May 2025
- Start date
- 9 Nov 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06979440
What you commit to
- Study type: Observational
- Planned participants: 40
- From 9 Nov 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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;
- Alcoholics or drug addicts;
Other illness
- Those with progressive serious diseases (such as cancer);
- Those with poor mental condition and unable to cooperate;
Other
- Those who do not meet the inclusion criteria;
- Those with severe aphasia, agnosia, and apraxia;
- Pregnant or breastfeeding women;
- Those who are considered unsuitable for inclusion in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.