Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Xiangya Hospital of Central South University
About this 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.
Eligibility criteria
Qualifiers
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%;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Berberine
- Inulin
- Berberine placebo tablets
- Inulin placebo tablets
Treatment groups
240 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov