Hyperglycaemia (Diabetic), Hyperlipidemias
Conditions
Keywords
Type 2 diabetes, Obesity, Omega-3 fatty acids
Brief summary
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.
Detailed description
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.
Interventions
DRUGLow dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year
DRUGHigh dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
DRUGControl drug
Matching placebo capsules,3 g/d by mouth for 1 year
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria; * BMI≥28 for obese groups; * Aged between 40 and 75 years.
Exclusion criteria
* Type 1 diabetes; * Cardiovascular disease; * Cancer; * Liver or kidney disease; * Premenopausal women, pregnancy or lactation; * Allergy to fish; * Have participated in other clinical trials in the last three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood lipids from baseline | 12 months | The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment. |
| Change in carotid plaque and carotid intima-meida thickness | 12 months | A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT). |
| Change in blood glucose from baseline | 12 months | The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood metabolome | 12 months | The investigators will collect blood samples from every participant and the UPLC-MS/MS method will be used to analyze the blood metabolomics profile. |
| Change in urinary protein concentration | 12 months | The investigators will collect urine sample from every participant and measure urinary protein before and after treatment. |
| Change in estimated glomerular filtration rate (eGFR) | 12 months | 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. |
| Change in gut microbiota from baseline | 12 months | The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota. |
| Change in sleep quality | 12 months | 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. |
| Change in cognitive function | 12 months | 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. |
| Change in bone mineral density (BMD) | 12 months | 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). |
| Change in body fat distribution | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in urine metabolome | 12 months | The investigators will collect urine samples from every participant and the UPLC-MS/MS method will be used to analyze the urine metabolomics profile. |
| Change in fecal metabolome | 12 months | The investigators will collect fecal samples from every participant and the UPLC-MS/MS method will be used to analyze the fecal metabolomics profile. |
Countries
China
Outcome results
None listed