A double-blind and placebo-controlled study is conducted in the current human study. The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.
Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
415
Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
Matching placebo capsules,3 g/d by mouth for 1 year
Lanxi Red Cross Hospital
Jinhua, Zhejiang, China
Change in blood glucose from baseline
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Time frame: 12 months
Change in blood lipids from baseline
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Time frame: 12 months
Change in carotid plaque and carotid intima-meida thickness
A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).
Time frame: 12 months
Change in gut microbiota from baseline
The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.
Time frame: 12 months
Change in sleep quality
The investigators will measure the Pittsburgh Sleep Quality Index (PSQI) through face-to-face questionnaire before and after treatment. The PSQI ranges from 0 to 21, with a higher score indicating a worse sleep quality.
Time frame: 12 months
Change in cognitive function
The investigators will do the mini-mental state examination (MMSE) before and after treatment. The MMSE score ranges from 0 to 30, with higher scores indicative of superior cognitive functioning.
Time frame: 12 months
Change in bone mineral density (BMD)
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The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the bone mineral density (BMD).
Time frame: 12 months
Change in body fat distribution
The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the total and regional body fat mass (FM) and then percentages of regional body fat will be calculated.
Time frame: 12 months
Change in urinary protein concentration
The investigators will collect urine sample from every participant and measure urinary protein before and after treatment.
Time frame: 12 months
Change in estimated glomerular filtration rate (eGFR)
The investigators will collect blood sample from every participant and measure blood creatinine before and after treatment. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation will be used to calculate the eGFR.
Time frame: 12 months
Change in blood metabolome
The investigators will collect blood samples from every participant and the UPLC-MS/MS method will be used to analyze the blood metabolomics profile.
Time frame: 12 months