Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity… (NCT05647915) | Clinical Trial Compass
CompletedPhase 4
Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD
China337 participantsStarted 2023-07-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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-phospha…
What they're measuring
1
Change of visceral fat content
Timeframe: 6 months
2
Change of liver fat content
Timeframe: 6 months
Trial details
NCT IDNCT05647915
SponsorChina National Center for Cardiovascular Diseases