Effects Of Berberine Plus Inulin On Diabetes Care in Elder Patients With LADA

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA aged over 60 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Treatments: Insulin

Criteria

Inclusion Criteria:

1. Diabetes diagnosed according to the report of WHO in 1999；

2. Meet the Chinese Diabetes Society diagnostic criteria (2012) for LADA: (1)glutamic acid decarboxylase antibody (GADA) positive; (2) age at diagnosis ≧ 18 years old; (3) independent on insulin for more than 6 months after diagnosis;

3. Age ≧ 60 years old;

4. 7.0%≤HbA1c ≤10.0%;

5. BMI ≥ 18.5 kg/m2, and no more than 37.5 kg/m2;

6. Written informed consent from the patient or family representative.

Exclusion Criteria:

1. Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection);

2. eGFR < 50ml/(min • 1.73 m2);

3. Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit;

4. History of any malignancy;

5. Pregnancy, breastfeeding, or planned pregnancy during the study period;

6. Secondary diabetes;

7. Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma);

8. Severe organic heart disease, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, etc., New York Heart Association (NYHA) heart function classification ≥Grade III;

9. Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months，or use of antibiotic medications or other interventions that could affect the gastrointestinal tract for 2 months before the screening and during the whole study period.

10. History of hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency.

11. Allergic to berberine or any components in the combinations.