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

Primary Purpose

Hyperglycaemia (Diabetic), Hyperlipidemias

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Low dose omega-3 fatty acid supplementation
High dose omega-3 fatty acid supplementation
Control drug
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycaemia (Diabetic) focused on measuring Type 2 diabetes, Obesity, Omega-3 fatty acids

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lanxi Red Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose group

High dose group

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2018
Last Updated
October 14, 2018
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03708887
Brief Title
The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycaemia (Diabetic), Hyperlipidemias
Keywords
Type 2 diabetes, Obesity, Omega-3 fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Low dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1 gram per day for 1 year.
Arm Title
High dose group
Arm Type
Experimental
Arm Description
High dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 gram per day for 1 year.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control drug, matching placebo capsules, 1 gram per day for 1 year.
Intervention Type
Drug
Intervention Name(s)
Low dose omega-3 fatty acid supplementation
Other Intervention Name(s)
Fish oil supplement
Intervention Description
Omega-3 fatty acids capsules, 1 g/d by mouth for 1 year
Intervention Type
Drug
Intervention Name(s)
High dose omega-3 fatty acid supplementation
Other Intervention Name(s)
Fish oil supplement
Intervention Description
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
Intervention Type
Drug
Intervention Name(s)
Control drug
Other Intervention Name(s)
Placebo drug
Intervention Description
Matching placebo capsules,1 g/d by mouth for 1 year
Primary Outcome Measure Information:
Title
Change in blood glucose from baseline
Description
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Time Frame
12 months
Title
Change in blood lipids from baseline
Description
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in gut microbiota from baseline
Description
The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Jiao, PHD
Phone
86-571-88982559
Email
jingjingjiao@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhang, PHD
Email
y_zhang@zju.edu.cn
Facility Information:
Facility Name
Lanxi Red Cross Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifang Zheng, MD
First Name & Middle Initial & Last Name & Degree
Yu Zhang, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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