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Study on the Efficacy ofMulberry Twig Total Alkaloids Tablets in Pediatric Patients with Obesity and Type 2 Diabetes Mellitus and Its Mechanisms for Improving Glucose and Lipid Metabolism

Study on the Efficacy ofMulberry Twig Total Alkaloids Tablets in Pediatric Patients with Obesity and Type 2 Diabetes Mellitus and Its Mechanisms for Improving Glucose and Lipid Metabolism

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125742
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Type 2 diabetes with obesity

Interventions

Experimental group:All patients were provided with a diabetic diet and lifestyle management, with insulin therapy administered based on blood glucose levels. Sangzhi Total Alkaloid Tablets were prescr
after one month, the dose was adjusted to 100mg per dose, three times daily, taken with meals
Control group:All patients were given diet and lifestyle management for diabetes, and insulin therapy was applied according to blood sugar,Metformin tablets, 500 mg/time, three times a day, taken oral

Sponsors

Capital Medical University Affiliated Capital Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for pediatric T2DM; 2. Age range: 10 to 18 years old; 3. Poor blood sugar control (HbA1c above 6.5%); 4. BMI exceeding the 85th percentile for children of the same age and gender; 5. ALT/AST = 60 mL/min/1.73m²;R1: "Diabetes" must be translated as diabetes. 6. No episodes of diabetic ketoacidosis or severe hypoglycemia (blood glucose <3.0 mmol/L with symptoms) in the past 1 month; 7. Guardians and subjects sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Other types of diabetes (such as MODY, secondary diabetes); 2. Allergic or intolerant to alpha glucosidase inhibitors; 3. History of severe complications of diabetes; 4. Serious cardiovascular diseases and autoimmune diseases; 5. History of gastrointestinal diseases or pancreatic diseases; 6. Have used oral medications that affect blood sugar or weight in the past 3 months; 7. Chronic gastrointestinal dysfunction, significant digestive and absorption disorders, or endocrine disorders; 8. Participate in clinical trials of other drugs or medical devices within the first 3 months; 9. Unable to complete the expected treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c;

Secondary

MeasureTime frame
Fasting blood glucose;fasting C-peptide;Fasting insulin;2-hour postprandial blood glucose;Oral glucose tolerance test;red blood cell count;Hemoglobin;Platelet count;white blood cell count;Neutrophil count;Lymphocyte count;Total protein;Albumin;Creatinine;Urea nitrogen;Alkaline phosphatase;Total bilirubin;Direct bilirubin;Alanine aminotransferase (ALT);Aspartate aminotransferase;Lactate dehydrogenase;uric acid;urinary white blood cells;liver ultrasound;glycosuria;occult blood in urine;Red blood cells in urine;proteinuria;ketone bodies;Urinary microalbumin;Total Cholesterol;triglyceride;High density lipoprotein;Low density lipoprotein;

Countries

China

Contacts

Public ContactCao Bingyan

Beijing Children's Hospital, Capital Medical University

caoby1982@163.com+86 138 1174 8954

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026