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Effects of compound probiotics combined with metformin on blood glucose, pancreatic islet function and insulin resistance in patients with type two diabetes mellitus

Effects of compound probiotics combined with metformin on blood glucose, pancreatic islet function and insulin resistance in patients with type two diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050108
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Type 2 diabetes mellitus (T2DM)

Interventions

Placebo group:metformin combined with placebo
Probiotic group:metformin combined with compound probiotics

Sponsors

Inner Mongolia People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as ''T2DM'', in line with ADA/WHO standards; 2. No gender limit, aged 20-65 years; 3. The duration of diabetes is >=3 months; 4. Simple diet control or oral metformin; or other drugs but discontinued for more than 3 months; 5. 6.5%<=glycated hemoglobin<=8.5%; 6. No antibiotics were taken 1 month before enrollment; 7. No history of chronic gastrointestinal diseases; 8. Those who agree to participate in this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant, breastfeeding, or planning to become pregnant within 6 months; 2. Patients with hepatic insufficiency: alanine aminotransferase and aspartate aminotransferase >= 2 times or more of the upper limit of the normal value; 3. Patients with renal insufficiency: Glomerular filtration rate (GFR)<=90ml/min; 4. Those suffering from endocrine diseases such as hypercortisolism and hyperthyroidism that affect glucose metabolism; 5. Severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebral infarction; 6. Suffering from infectious diseases, including tuberculosis and AIDS; 7. Accompanied by severe DM complications (proliferative retinopathy, kidney damage above stage IV, diabetic foot infection and severe diabetic neuropathy); 8. Alcoholism.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin;Blood glucose;Intestinal flora;

Secondary

MeasureTime frame
Blood uric acid;Blood lipids;Insulin;

Countries

China

Contacts

Public ContactChen Ye

Inner Mongolia People's Hospital

5117149cy@sina.com+86 18047122705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026