NCT03708887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 12, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

October 14, 2018

Last Update Submit

July 10, 2024

Conditions

Hyperglycaemia (Diabetic)Hyperlipidemias

Keywords

Type 2 diabetesObesityOmega-3 fatty acids

Outcome Measures

Primary Outcomes (3)

  • Change in blood glucose from baseline

    The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.

    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.

    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).

    12 months

Secondary Outcomes (8)

  • Change in gut microbiota from baseline

    12 months

  • Change in sleep quality

    12 months

  • Change in cognitive function

    12 months

  • Change in bone mineral density (BMD)

    12 months

  • Change in body fat distribution

    12 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Change in fecal metabolome

    12 months

  • Change in urine metabolome

    12 months

Study Arms (3)

Low dose group

EXPERIMENTAL

Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year.

Drug: Low dose omega-3 fatty acid supplementation

High dose group

EXPERIMENTAL

High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year.

Drug: High dose omega-3 fatty acid supplementation

Control group

PLACEBO COMPARATOR

Control drug, matching placebo capsules, 3 grams per day for 1 year.

Drug: Control drug

Interventions

Low dose omega-3 fatty acid supplementationDRUG

Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year

Also known as: Fish oil supplement
Low dose group
High dose omega-3 fatty acid supplementationDRUG

Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year

Also known as: Fish oil supplement
High dose group
Control drugDRUG

Matching placebo capsules,3 g/d by mouth for 1 year

Also known as: Placebo drug
Control group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
  • BMI≥28 for obese groups;
  • Aged between 40 and 75 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanxi Red Cross Hospital

Jinhua, Zhejiang, 321102, China

Location

Related Publications (2)

  • Zhuang P, Liu X, Jia W, Zheng W, Wan X, Chen W, Gu J, Li Y, Lan X, Li H, Tong W, Wu Y, Wu X, Ao Y, Ye H, Wu F, Zhu L, Zhang L, Li Y, Meng D, Tian Y, Wang A, Wu S, Zhu F, Zhang Y, Shi H, Yu X, Zhang F, Zhang Y, Jiao J. Marine n-3 fatty acid treatment for carotid plaques in patients with type 2 diabetes. Cardiovasc Diabetol. 2026 Jan 20. doi: 10.1186/s12933-026-03082-7. Online ahead of print.

    PMID: 41559698DERIVED

  • Zhuang P, Wu Y, Yao J, Liu X, Liu H, Wan X, Jia W, Wang T, Zhang Y, Jiao J. Marine n-3 polyunsaturated fatty acids slow sleep impairment progression by regulating central circadian rhythms in type 2 diabetes. Cell Rep Med. 2025 May 20;6(5):102128. doi: 10.1016/j.xcrm.2025.102128. Epub 2025 May 9.

    PMID: 40347940DERIVED

MeSH Terms

Conditions

HyperglycemiaHyperlipidemiasDiabetes Mellitus, Type 2Obesity

Interventions

Drug and Narcotic Control

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersDiabetes MellitusEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Legislation, DrugLegislation as TopicSocial Control, FormalHealth Care Economics and OrganizationsPharmacy AdministrationOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 17, 2018

Study Start

October 10, 2020

Primary Completion

January 2, 2022

Study Completion

February 28, 2022

Last Updated

July 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)