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

• Status: Not yet recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases

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