Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: A Randomized Controlled Trial
Trial ID: NCT04698330
Interventional - Phase 4 - Not yet recruiting
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.
Conditions
Type 1 Diabetes Mellitus
Autoimmune Diabetes
Interventions
Berberine
Inulin
Berberine placebo tablets
Inulin placebo tablets
Eligibility
Inclusion criteria
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. Aged between 18 and 70 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
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.
Sponsor
Second Xiangya Hospital of Central South University