Type 2 diabetes combined with high BMI
Conditions
Interventions
Compound probiotic test group:Combined intervention with probiotic complex (3g/day) and metformin (0.5g/day)
Placingbo control group:Combined intervention with placingbo (3g/day) and metformin (0.5g/day)
Sponsors
The First Hospital Affiliated of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 30 to 65 years old, males or females, willing to participate in this study, with good compliance, and willing to sign an informed consent form; (2) Dysglycemia: 6.5% = HbA1c = 8.5%, diagnosed with type 2 diabetes according to the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus (2020 Edition), and diabetes duration = 3 months; (3) Dietary control or oral metformin alone; or other drugs previously used but discontinued for more than 3 months; (4) BMI: 24 = BMI = 32 kg/m2; (5) Did not use lipid-lowering drugs, or received lipid-lowering drugs and stopped taking them for more than 3 months.
Exclusion criteria
Exclusion criteria: (1) Women preparing for pregnancy, pregnant or breastfeeding, pregnant or planning to become pregnant within 6 months of enrollment; (2) Having a history of long-term glucocorticoid use or having used antibiotics in the last month; (3) Patients with hereditary (familial) hyperlipidemia (more than 2 immediate family members with the same type of hyperlipidemia), with a hyperlipidemic phenotype at risk for acute pancreatitis; (4) Presence of acute or chronic progressive or chronic unstable disease, with known renal insufficiency (in patients with renal insufficiency: glomerular filtration rate (GFR) = 90 ml/min), hepatic insufficiency (those with glutamic transaminase and glutamic oxal transaminase = 2 times the high limit of the normal value and above), malignant tumors, infectious diseases (tuberculosis and AIDS, etc.), or autoimmune diseases, and other serious diseases considered by the investigator as unsuitable for enrollment; (5) Hypertensive individuals whose blood pressure remains higher than 160/100 mm Hg despite routine treatment with antihypertensive medications; (6) Have previous bariatric surgery, any surgery within 3 months prior to the experiment or within 6 months of the post-enrollment program; (7) Subjects who have taken psychiatric samples such as anti-anxiety and antidepressant samples in the last 1 month, and who have a major psychiatric disorder that makes it difficult for them to control their actions and cooperate; (8) Patients suffering from endocrine diseases affecting glucose metabolism such as hypercortisolism and hyperthyroidism; (9) With severe diabetic complications (value-added retinopathy, stage IV or higher kidney damage, diabetic foot infections and severe diabetic neuropathy); (10) Any other reason for which the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;HOMA-IR;FBS;C-peptide;FI; | — |
Secondary
| Measure | Time frame |
|---|---|
| TC;TG;HDL-C;LDL-C;Apolipoprotein A1;Apolipoprotein B;Blood Uric Acid;Questionnaire indicators;AE;SAE;ADR;SADR; | — |
Countries
China
Contacts
Public ContactXie Wenrui
The First Hospital Affiliated of Guangdong Pharmaceutical University
Outcome results
None listed