[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591362":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":26,"locations":37,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (with type 2 diabetes)",null,"The clinical inclusion criteria are as follows:\n\na. 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.",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"T2DD (with type 2 diabetes complicated with depression)","The clinical inclusion criteria are as follows:\n\na. 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.",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":10},"No intervention",[9,15],[23],{"name":24,"affiliation":5,"role":25},"zhengwei zhang, PhD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Zhengwei Zhang, PhD","CONTACT","15701539317","+86","zhangzhengwei95@foxmail.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Zheng Yang, MD","0513-85052230","zzw3737@126.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Nantong","Jiangsu","226001","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.87472,32.03028,{"lat":49,"lon":48},[52],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":67,"type":68},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.",[73],"Diabetes-Related Complications",[75,76,77],"Type 2 diabetes mellitus","depression","Diabetes Complications","2025-05-22",{"date":80,"type":81},"2025-05-28","ACTUAL",{"date":83,"type":81},"2024-11-09",{"date":85,"type":68},"2027-12-31",{"name":5,"class":6},1]