Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals With Obesity and NAFLD

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Dec 4, 2022

Keywords

ClinConnect Summary

The trial aims to evaluate the efficacy and safety of berberine treatment for obesity and NAFLD. Potential eligible patients will be recruited from 10-20 medical centers in China. After a 4-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 1.0 g per day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be asked to attend the visit at least once every 2 months, and be followed up for 6 months.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants aged ≥18 years
• • Participants with obesity (i.e., BMI ≥ 28 kg/m2) and abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
• • Participants with NAFLD diagnosed by ultrasound, computed tomography or magnetic resonance imaging
• Exclusion Criteria:
• • Patients with established coronary heart disease, stroke, or peripheral arterial disease
• • Patients diagnosed with diabetes or taking oral glucose-lowering drugs
• • Patients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)
• • Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)
• • Other causes of fatty liver disease, including alcohol or drug abuse, hepatitis B or C, autoimmune, hepatolenticular degeneration, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, β -lipoprotein deficiency, lipid atrophy diabetes, Mauriac syndrome, etc.
• • Patients with thyroid disease, including hyperthyroidism or hypothyroidism
• • Patients with cardiac insufficiency
• • ALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiency
• • Patients with renal insufficiency: estimated glomerular filtration rate (eGFR) \< 60 ml/(min×1.73m2)
• • Patients who had weight loss surgery, or are currently taking drugs for weight loss, or plan to have weight loss surgery or drugs in the following 6 months
• • Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
• • Taking berberine or drug containing berberine in the past 1 month
• • Any adverse reaction to berberine
• • Severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
• • Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkers
• • Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial
• • Patients with malignant tumors
• • Patients with mental disorders, cognitive disorders, and/or other serious diseases
• • Those who participated or have been participating other trials during the last 3 months
• • Any other conditions that may hinder the compliance to the study intervention or follow-up visit

Trial Officials