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Starting soon Phase 4

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

NCT04698330 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2022-05
Last updated
2022-02-25

Condition(s) studied

Type 1 Diabetes MellitusAutoimmune Diabetes

Investigational drug(s) / intervention(s)

Berberine →InulinBerberine placebo tabletsInulin placebo tablets

Berberine: 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal for 3 months

Inulin: 0.6g (6 pills) of Inulin tablets administered twice a day orally before meal for 3 months

Berberine placebo tablets: 0.6g (6 pills) of Berberine placebo tablets administered twice a day orally before meal for 3 months

Inulin placebo tablets: 0.6g (6 pills) of Inulin placebo tablets administered twice a day orally before meal for 3 months

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in HbA1c — 1 year after start of trial
    The primary outcome measure is the change in mean HbA1c level, reflecting the blood glucose management status of the patients.

Trial sites (1)

FacilityCityRegionStatus
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Changsha Hunan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04698330 on ClinicalTrials.gov ↗ ← All trials in China