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The effects of total alkaloids from mulberry branches on liver function and relevant metabolic indicators in patients with type 2 diabetes mellitus combined with fatty liver disease

The effects of total alkaloids from mulberry branches on liver function and relevant metabolic indicators in patients with type 2 diabetes mellitus combined with fatty liver disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110519
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Type 2 diabetes combined with metabolic associated fatty liver disease

Interventions

Control group: conventional glucose-lowering treatment group:None
Experimental group: Mulberry twig total alkaloid tablet treatment group:None

Sponsors

Zunyi Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age range is 18-70 years; 2. Diagnosis of T2DM and MASLD (abdominal ultrasound, liver biopsy not required); 3. BMI 24-30 kg/m^2 (overweight); 4. Baseline HbA1c level for blood glucose control: 7.0%-10.0%; 5. Fasting blood glucose >=7.0 mmol/L and <=13.9 mmol/L; 6. Voluntarily accept treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of allergy to mulberry branch components; 2. Moderate to severe renal impairment (eGFR = 2.5 times the upper normal limit; 4.Acute or chronic metabolic acidosis, including diabetic ketoacidosis with a history of irregular intake of lipid-lowering medications; 5. Severe heart disease, myocardial infarction, unstable angina, or chronic heart failure (New York Heart Association Class III or IV); 6. Poor blood pressure control (BP) (systolic BP >= 160 mmHg or diastolic BP >= 100 mmHg); 7. New use of hypoglycemic or lipid-lowering medications in the existing medication regimen within the past 3 months; 8. Exclusion of participants taking more than 3 hypoglycemic medications at screening (counting according to the number of active ingredients in combinations); 9. Mental or neurological disorders and inability to express wishes correctly; 10. Participation in a clinical trial of other medications or medical devices within the past month; 11. Excessive alcohol consumption (men intermittently consuming more than 30g/d; women > 20g/d) or drug abuse or addiction; 12. Pregnancy or planned pregnancy; 13. Those deemed unsuitable for enrollment by the researcher.

Design outcomes

Primary

MeasureTime frame
gamma-glutamyl transferase;

Secondary

MeasureTime frame
Controlled Attenuation Parameter;Liver Stiffness Measurement;Glycated hemoglobin;Fasting Blood Glucose;Blood sugar 1 hour after a meal;Blood sugar 2 hour after a meal;Body Mass Index;Alanine aminotransferase;Aspartate aminotransferase;Total cholesterol;Triglycerides;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;

Countries

China

Contacts

Public ContactXin Liao

Zunyi Medical University Affiliated Hospital

liaoxin8618@163.com+86 135 9520 8618

Outcome results

None listed

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