Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD
- Conditions
- Obesity, AbdominalNAFLDObesity
- Interventions
- Behavioral: Placebo plus lifestyle intervention
- Registration Number
- NCT05647915
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Placebo plus lifestyle intervention Placebo plus lifestyle intervention berberine group Berberine plus lifestyle intervention Berberine hydrochloride plus lifestyle intervention
- Primary Outcome Measures
Name Time Method Change of visceral fat content 6 months Measurement of visceral fat by computed tomography
Change of liver fat content 6 months Measurement of liver fat content by computed tomography
- Secondary Outcome Measures
Name Time Method Change of low-density lipoprotein cholesterol 6 months Measurement of low-density lipoprotein cholesterol
Change of serum triglyceride 6 months Measurement of serum triglyceride (TG)
Change of fasting plasma glucose 6 months Measurement of fasting plasma glucose (FPG)
Change of HbA1c 6 months Measurement of HbA1c
Change of 2-hour postprandial blood glucose 6 months Measurement of 2-hour postprandial blood glucose (2hPG)
Change of homeostatic model assessment-insulin resistance 6 months Homeostatic model assessment-insulin resistance (HOMA-IR)= (fasting insulin (mIU/L) \* FPG (mmol/L)) / 22.5
Change of homeostasis model assessment-insulin sensitivity 6 months Homeostatic model assessment-insulin sensitivity (HOMA-IS)= 1/ HOMA-IR
Change of high-density lipoprotein cholesterol 6 months Measurement of high-density lipoprotein cholesterol
Change of total cholesterol 6 months Measurement of total cholesterol
Change of lipoprotein (a) 6 months Measurement of lipoprotein (a)
Change of apolipoprotein 6 months Measurement of apolipoprotein
Change of metabolic syndrome z-score 6 months Metabolic syndrome z-score calculated by the five components, including waist circumference, HDL-C, blood pressure, TG and FPG. Higher score indicates greater severity of metabolic syndrome
Change of fat liver index 6 months Fat liver index (FLI) calculated by TG, body mass index, gamma-glutamyltransferase (γ-GGT), waist circumference. Higher index indicates higher content of liver fat
Change of body mass index 6 months Weight and height will be combined to report BMI in kg/m\^2
Change of waist-hip ratio 6 months Waist circumference and hip circumference will be combined to report waist-hip ratio.
Change of systolic blood pressure 6 months Measurement of systolic blood pressure (SBP)
Change of diastolic blood pressure 6 months Measurement of diastolic blood pressure (DBP)
Change of homeostasis model assessment-β cell 6 months Homeostatic model assessment (HOMA-β) = (20 x fasting insulin (mIU/L)) / (FPG (mmol/L) - 3.5)
Change of serum homocysteine 6 months Measurement of serum homocysteine
Change of body weight 6 months Measurement of body weight in kg
Change of waist-height ratio 6 months Waist circumference and height will be combined to report waist-height ratio.
Change of visceral fat index 6 months Visceral fat index calculated by waist circumference, body mass index, TG, HDL-C. Higher index indicates higher content of visceral fat
Change of triglyceride glucose index 6 months Triglyceride glucose index (TyG) calculated by TG and FPG. Higher index indicates higher insulin resistance
Change of serum urine acid 6 months Measurement of serum urine acid
Normalization of glucose parameters among participants with prediabetes 6 months Meeting all three criteria: 1) FPG\<6.1 mmol/L; 2) 2hPG\<7.8 mmol/L; 3) HbA1c\<5.7%
Change of waist circumference 6 months Measurement of waist circumference in cm
Trial Locations
- Locations (1)
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
🇨🇳Beijing, China