The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients

Hyperlipidemias Clinical Trial

Official title:

Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03708887
• Other study ID #: RCT-N3
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2018
• Source: Zhejiang University
• Contact: Jingjing Jiao, PHD
• Phone: 86-571-88982559
• Email: jingjingjiao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind and placebo-controlled study was conducted in 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.

Description:

Approximately 450 obese and 450 diabetic 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed type 2 diabetes for diabetic groups according to WHO (1999) diagnostic criteria;

• BMI=24 for obese/overweight groups;

• Aged between 50 and 70 years.

Exclusion Criteria:

• TG=4.56 mmol/L;

• Proliferative retinopathy;

• Pregnancy or lactation;

• Allergy to fish;

• Taking insulin;

• Premenopausal or menopause within 6 months;

• Have participated in other clinical trials in the last three months.

Related Conditions & MeSH terms

• Hyperglycaemia (Diabetic)
• Hyperglycemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Low dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 1 g/d by mouth for 1 year
• High dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
• Control drug
Matching placebo capsules,1 g/d by mouth for 1 year

Locations

Country	Name	City	State
China	Lanxi Red Cross Hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	12 months