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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05647915
Other study ID # 2021-CXGC04-2
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date December 15, 2022
Est. completion date December 15, 2023

Study information

Verified date December 2022
Source China National Center for Cardiovascular Diseases
Contact Haibo Zhang, MD
Phone +86 60866781
Email zhanghaibo@fuwai.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 326
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, ß -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


Related Conditions & MeSH terms


Intervention

Drug:
Berberine plus lifestyle intervention
berberine hydrochloride 500mg twice a day for 6 months plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.
Behavioral:
Placebo plus lifestyle intervention
Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

Locations

Country Name City State
China Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases Beijing

Sponsors (1)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (2)

Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A, Goldkind L, Di Bisceglie AM. A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes. Nat Commun. 2021 Sep 17;12(1):5503. doi: 10.1038/s41467-021-25701-5. — View Citation

Yan HM, Xia MF, Wang Y, Chang XX, Yao XZ, Rao SX, Zeng MS, Tu YF, Feng R, Jia WP, Liu J, Deng W, Jiang JD, Gao X. Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease. PLoS One. 2015 Aug 7;10(8):e0134172. doi: 10.1371/journal.pone.0134172. eCollection 2015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change of alanine aminotransferase Measurement of alanine aminotransferase (ALT) 6 months
Other Change of aspartate aminotransferase Measurement of aspartate aminotransferase (AST) 6 months
Other Change of ?-GGT Measurement of ?-GGT 6 months
Other Change of fibrosis-4 score Fibrosis-4 score (FIB-4) calculated by age, ALT, AST, platelet count. Higher score indicates higher extent of liver fibrosis. 6 months
Other Change of NAFLD fibrosis score NAFLD fibrosis score (NFS) calculated by age, BMI, status of dysglycemia, ALT, AST, platelet count, serum albumin concentration. Higher score indicates higher extent of liver fibrosis. 6 months
Other Change of hypersensitive C-reactive protein Measurement of hypersensitive C-reactive protein 6 months
Other Change of interleukin-6 Measurement of interleukin-6 (IL-6) 6 months
Other Change of tumor necrosis factor-a Measurement of tumor necrosis factor-a (TNF-a) 6 months
Other Change of transforming growth factor-ß Measurement of transforming growth factor-ß (TGF-ß) 6 months
Other Change of leptin Measurement of leptin 6 months
Other Change of adiponectin Measurement of adiponectin 6 months
Other Change of short chain fatty acids Measurement of short chain fatty acids 6 months
Other Change of trimethylamine Measurement of trimethylamine (TMA) 6 months
Other Change of trimethylamine oxide Measurement of trimethylamine oxide (TMAO) 6 months
Other Improvement of left ventricular diastolic function (LVDF) among participants with abnormal LVDF at baseline Measurement of LVDF by echocardiogram 6 months
Other Change of pericardial fat among participants with abnormal LVDF Measurement of pericardial fat by computed tomography 6 months
Primary Change of visceral fat content Measurement of visceral fat by computed tomography 6 months
Primary Change of liver fat content Measurement of liver fat content by computed tomography 6 months
Secondary Change of fasting plasma glucose Measurement of fasting plasma glucose (FPG) 6 months
Secondary Change of HbA1c Measurement of HbA1c 6 months
Secondary Change of 2-hour postprandial blood glucose Measurement of 2-hour postprandial blood glucose (2hPG) 6 months
Secondary Change of homeostatic model assessment-insulin resistance Homeostatic model assessment-insulin resistance (HOMA-IR)= (fasting insulin (mIU/L) * FPG (mmol/L)) / 22.5 6 months
Secondary Change of homeostasis model assessment-ß cell Homeostatic model assessment (HOMA-ß) = (20 x fasting insulin (mIU/L)) / (FPG (mmol/L) - 3.5) 6 months
Secondary Change of homeostasis model assessment-insulin sensitivity Homeostatic model assessment-insulin sensitivity (HOMA-IS)= 1/ HOMA-IR 6 months
Secondary Change of serum triglyceride Measurement of serum triglyceride (TG) 6 months
Secondary Change of high-density lipoprotein cholesterol Measurement of high-density lipoprotein cholesterol 6 months
Secondary Change of low-density lipoprotein cholesterol Measurement of low-density lipoprotein cholesterol 6 months
Secondary Change of total cholesterol Measurement of total cholesterol 6 months
Secondary Change of lipoprotein (a) Measurement of lipoprotein (a) 6 months
Secondary Change of apolipoprotein Measurement of apolipoprotein 6 months
Secondary Normalization of glucose parameters among participants with prediabetes Meeting all three criteria: 1) FPG<6.1 mmol/L; 2) 2hPG<7.8 mmol/L; 3) HbA1c<5.7% 6 months
Secondary Change of metabolic syndrome z-score 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 6 months
Secondary Change of visceral fat index Visceral fat index calculated by waist circumference, body mass index, TG, HDL-C. Higher index indicates higher content of visceral fat 6 months
Secondary Change of fat liver index Fat liver index (FLI) calculated by TG, body mass index, gamma-glutamyltransferase (?-GGT), waist circumference. Higher index indicates higher content of liver fat 6 months
Secondary Change of triglyceride glucose index Triglyceride glucose index (TyG) calculated by TG and FPG. Higher index indicates higher insulin resistance 6 months
Secondary Change of serum urine acid Measurement of serum urine acid 6 months
Secondary Change of serum homocysteine Measurement of serum homocysteine 6 months
Secondary Change of body weight Measurement of body weight in kg 6 months
Secondary Change of body mass index Weight and height will be combined to report BMI in kg/m^2 6 months
Secondary Change of waist circumference Measurement of waist circumference in cm 6 months
Secondary Change of waist-hip ratio Waist circumference and hip circumference will be combined to report waist-hip ratio. 6 months
Secondary Change of waist-height ratio Waist circumference and height will be combined to report waist-height ratio. 6 months
Secondary Change of systolic blood pressure Measurement of systolic blood pressure (SBP) 6 months
Secondary Change of diastolic blood pressure Measurement of diastolic blood pressure (DBP) 6 months
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