Tests berberine and inulin with insulin in adults with latent autoimmune diabetes
Tests berberine and inulin tablets alongside insulin in adults with slow-onset autoimmune diabetes.
Plain-language title generated from the registry record
Registry title: Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT04698330, who can take part
Where in China
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South UniversityChangsha, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Xiangya Hospital of Central South University
- Trial code
- NCT04698330
- Record updated
- 25 February 2022
- Original description
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.Read full original descriptionShow less
Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: A Randomized Controlled Trial
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.
Inclusion: Diabetes diagnosed according to the report of WHO in 1999；; 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; Aged between 18 and 70 years old; 7.0%≤HbA1c ≤10.0%; BMI ≥ 18.5 kg/m2, and no more than 37.5 kg/m2; Written informed consent from the patient or family representative.
Exclusion: Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit; 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; History of any malignancy; Secondary diabetes; 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; Allergic to berberine or any components in the combinations; Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection); eGFR < 50ml/(min • 1.73 m2); History of hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; Pregnancy, breastfeeding, or planned pregnancy during the study period; Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma).