Type 2 Diabetes Mellitus, Lipid Metabolism Disorder, Fatty Acid Metabolism Disorder
Conditions
Keywords
Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus
Brief summary
The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
Detailed description
The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.
Interventions
DIETARY_SUPPLEMENTomega-3 polyunsaturated fatty acids
Participants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.
DIETARY_SUPPLEMENTcorn oil
Participants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
The study was a randomised, double-blind trial, and neither the subjects nor the research workers knew the exact subgroups or the progress of the treatment
Intervention model description
The study was a randomised, double-blind trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes have been diagnosed; * Male or female aged 18-70 years; * After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.
Exclusion criteria
* Pregnant or lactating women; * Poorly controlled diabetes, i.e. HbA1c\>9%； * Have taken omega-3 PUFAs-related supplements in the past six months； * Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism； * Patients with severe diabetic complications, severe hypertension, combined with * diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis； * Patients with severe immune system disorders； * Have special diets: vegetarians, weight managers, ketogenic test takers, etc； * The attending physician deems the participant unsuitable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| height in meters | 12 weeks | physiological parameter |
| body mass index (BMI) | 12 weeks | BMI=weight(kg)/height\^2(m) |
| waist circumference | 12 weeks | physiological parameter |
| hip measurement | 12 weeks | physiological parameter |
| Systolic blood pressure | 12 weeks | physiological parameter |
| Diastolic blood pressure | 12 weeks | physiological parameter |
| Concentration of Serum triglycerides | 12 weeks | physiological parameter |
| Concentration of total cholesterol | 12 weeks | physiological parameter |
| weight in kilograms | 12 weeks | physiological parameter |
| Concentration of low-density lipoprotein cholesterol | 12 weeks | physiological parameter |
| Concentration of high-density lipoprotein cholesterol | 12 weeks | physiological parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who take drugs | 12 weeks | This indicator refers to the number of participants taking medication. |
| Incidence of diabetes complications | 12 weeks | This indicator refers to the proportion of participants experiencing complications from diabetes. |
| Rate of smoking among participants | 12 weeks | This indicator refers to the proportion of participants who smoke. |
Countries
China
Outcome results
None listed