prediabetes
Conditions
Interventions
treatment group:The treatment group will receive a daily dose of Christensenella minuta SJ-2 preparation containing 10^10 CFU of live bacteria for 12 weeks.
control group:The control group will receive a placebo of the same specification as the treatment group but without the active ingredient, for 12 weeks.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–70 years; 2.Meet the diagnostic criteria for prediabetes, as defined by at least one of the following: fasting plasma glucose 5.6–6.9 mmol/L; 2-hour OGTT plasma glucose 7.8–11.0 mmol/L; glycated hemoglobin (HbA1c) 5.7%–6.4%.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with diabetes, hyperlipidemia, or other metabolic diseases, or having received medication or intervention according to the treatment standards for diabetes, hyperlipidemia, or other metabolic diseases within the past 1 month; 2.Severe systemic diseases, mental disorders, or severe infections; 3.Pregnant or lactating women, or individuals planning pregnancy; 4.Use of live bacterial preparations, prebiotics, antimicrobial agents, immunosuppressants, glucocorticoids, or long-term use of traditional Chinese medicine within the past 1 month; 5.Use of non-steroidal anti-inflammatory drugs, bile acid sequestrants, or ursodeoxycholic acid within the past 2 weeks; 6.Allergic diseases or use of oral antihistamines; 7.Significant motor impairment; 8.History of long-term alcohol consumption or heavy alcohol consumption within the past 2 weeks; 9.Poor compliance as judged by the physician, or deemed unsuitable for participation in this clinical study after evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in sugar metabolism ;glycated albumin;Continuous glucose monitoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin; blood lipid;pancreas islet function;body weight;body mass index;Gut microbiome;Detection amount of Christensenella minuta strain in feces;Gastrointestinal Symptom Rating Scale;stool consistency;Abdominal Discomfort; Adverse Event/Serious Adverse Event Reporting Form;blood routine test;Liver Function;Kidney Function;Blood Clotting;CRP;Albumin;LPS;Metabolite components;Metabolites associated with Christensenella minuta; | — |
Countries
China
Contacts
Public ContactDuan Liping
Peking University Third Hospital
Outcome results
None listed