[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-related-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-related-complications":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100591362","study-on-the-molecular-mechanism-of-berberine-to-improve-type-2-diabetes-mellitus-complicated-with-depression-100591362",false,"NCT06979440","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.","SBDD","Inclusion Criteria:\n\n1. Aged 18-65 years (including the critical value), regardless of gender;\n2. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;\n3. 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;\n4. The subjects read and fully understood the patient instructions and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Those who do not meet the inclusion criteria;\n2. 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;\n3. Those with progressive serious diseases (such as cancer);\n4. Those with severe aphasia, agnosia, and apraxia;\n5. 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;\n6. Pregnant or breastfeeding women;\n7. Alcoholics or drug addicts;\n8. Those with poor mental condition and unable to cooperate;\n9. Those who are considered unsuitable for inclusion in the study.","ALL","18 Years","65 Years",{"count":21,"type":22},40,"ESTIMATED","3 Years","OBSERVATIONAL","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.\n\nThe 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.",[27],"Diabetes-Related Complications",[29,30,31],"Type 2 diabetes mellitus","depression","Diabetes Complications","RECRUITING","2025-05-22",{"date":35,"type":36},"2025-05-28","ACTUAL",{"date":38,"type":36},"2024-11-09",{"date":40,"type":22},"2027-12-31",{"name":42,"class":43},"Affiliated Hospital of Nantong University","OTHER"]