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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperglycaemia (Diabetic), Hyperlipidemias

Intervention / Treatment
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* Drug: Low dose omega-3 fatty acid supplementation
* Drug: High dose omega-3 fatty acid supplementation
* Drug: Control drug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>Low dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1 gram per day for 1 year. | Drug: Low dose omega-3 fatty acid supplementation<br>* Omega-3 fatty acids capsules, 1 g/d by mouth for 1 year<br>* Other names: Fish oil supplement;|
| Experimental: High dose group<br>High dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 gram per day for 1 year. | Drug: High dose omega-3 fatty acid supplementation<br>* Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year<br>* Other names: Fish oil supplement;|
| Placebo Comparator: Control group<br>Control drug, matching placebo capsules, 1 gram per day for 1 year. | Drug: Control drug<br>* Matching placebo capsules,1 g/d by mouth for 1 year<br>* Other names: Placebo drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Type 2 diabetes, Omega-3 fatty acids