Not Yet RecruitingPhase 4

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

China240 participantsStarted 2022-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Change in HbA1c

Timeframe: 1 year after start of trial

Trial details

NCT IDNCT04698330

SponsorSecond Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Yang Xiao, MD/PhD

86-731-85292154 xiaoyang29@csu.edu.cn

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials