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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jan 5, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a treatment that combines berberine and inulin with insulin therapy for people with LADA, which is a type of diabetes that shares features of both Type 1 and Type 2 diabetes. The goal is to see if this combination can help improve diabetes management for patients. The study is not yet recruiting participants, but it will be open to individuals aged 18 to 70 who have been diagnosed with LADA and are currently managing their diabetes with insulin.

To be eligible for this trial, participants must have specific criteria, such as being GADA positive (which means their body has certain antibodies related to diabetes), having an HbA1c level between 7.0% and 10.0%, and a Body Mass Index (BMI) within a certain range. However, those with severe liver problems, certain heart conditions, or who are pregnant or breastfeeding will not be able to participate. If you or a family member are interested, you can expect to be part of a study that aims to find better ways to manage diabetes, with close monitoring and support from the research team throughout the trial.

Gender

ALL

Eligibility 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. 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:
• • 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.