Status:
NOT_YET_RECRUITING
Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Type 1 Diabetes Mellitus
Autoimmune Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Latent autoimmune diabetes in adults (LADA) is a hybrid form of diabetes, characterized by autoimmune destruction of pancreatic β-cells as well as insulin resistance and is triggered by environmental ...
Eligibility Criteria
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
- Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection);
- eGFR \< 50ml/(min • 1.73 m2);
- Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit;
- History of any malignancy;
- Pregnancy, breastfeeding, or planned pregnancy during the study period;
- Secondary diabetes;
- Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma);
- 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;
- 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 hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency.
- Allergic to berberine or any components in the combinations.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04698330
Start Date
May 1 2022
End Date
December 1 2026
Last Update
February 25 2022
Active Locations (1)
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1
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011