Clinical trial NCT06061510: Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus
Official title: Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lipid Metabolism Disorder
Fatty Acid Metabolism Disorder
Keywords: Omega-3 Fatty Acids
Gut Microbiota
lipid Metabolome
glycerophospholipid
Type 2 Diabetes Mellitus
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2023-09-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a randomised, double-blind trial.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of Serum triglycerides
timeFrame: 12 weeks
measure: Concentration of total cholesterol
timeFrame: 12 weeks
measure: Concentration of low-density lipoprotein cholesterol
timeFrame: 12 weeks
measure: Concentration of high-density lipoprotein cholesterol
timeFrame: 12 weeks
measure: weight in kilograms
timeFrame: 12 weeks
measure: height in meters
timeFrame: 12 weeks
measure: body mass index (BMI)
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: hip measurement
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants who take drugs
timeFrame: 12 weeks
measure: Incidence of diabetes complications
timeFrame: 12 weeks
measure: Rate of smoking among participants
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Southeast university
state: Jiangsu
Study officials:
References: