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Regulatory mechanism of intestinal flora in metformin treatment of schizophrenia drug-induced metabolic disorder

Regulatory mechanism of intestinal flora in metformin treatment of schizophrenia drug-induced metabolic disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045240
Enrollment
Unknown
Registered
2021-04-09
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

the patients with first-episode schizophrenia, without medication and no metabolic syndrome:Null
Schizophrenia with metabolic syndrome caused by second-generation anti-schizophrenics:without metformin intervention
Second-generation anti-schizophrenia drug induced metabolic syndrome in schizophrenia:metformin

Sponsors

Hefei Fourth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. First-episode schizophrenic patients without metabolic syndrome: (1) Meet the diagnostic criteria of dsm-5 for schizophrenia; (2) No antipsychotic treatment and no metabolic syndrome; (3) Aged between 18 and 65 years; (4) The Han people live in the same area without special religion; (5) Sign informed consent. 2. Intervention group and non intervention group for schizophrenia patients with metabolic syndrome induced by second generation antipsychotics: (1) The diagnostic criteria of dsm-5 were met; (2) The intervention group received metformin hydrochloride enteric coated tablets 0.5 g twice a day. (3) Received antipsychotic treatment and the total treatment days were more than 1 month; 3. Normal control group: (1) Age, gender, BMI, eating habits, spouse of patients,the living area matched with case group or healthy control without blood relationship; (2) Dietary habits, drinking status and body mass index were matched with the disease group; (3) No other drugs were taken in the first 4 weeks.

Exclusion criteria

Exclusion criteria: 1. With major infectious and infectious diseases; 2. History of major neurological diseases, growth and developmental diseases, brain trauma, major somatic diseases and drug dependence; 3. Any chronic disease or disease that may affect the stability of intestinal flora, such as hypertension, immune deficiency, etc; 4. Severe diarrhea, severe constipation, hemorrhoids, gastroscopy, colonoscopy or barium meal in recent 3 months; 5. Infection occurred in the last 6 months; 6. Used antibiotics, glucocorticoids, cytokines, high-dose probiotics or biological agents in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;

Countries

China

Contacts

Public ContactZhu Cuizhen

Hefei Fourth People's Hospital

zhucuizhenhi@163.com+86 13705535258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026