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Completed

NCT Number: NCT03708887

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

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.

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Key information

Conditions

Hyperglycaemia (Diabetic) Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lanxi Red Cross Hospital

Jinhua, Zhejiang, 321102, China

About this study

Approximately 450 diabetic and 450 obese 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 (1.5 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. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Low dose omega-3 fatty acid supplementation

Drug

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

Other names: Fish oil supplement

High dose omega-3 fatty acid supplementation

Drug

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

Other names: Fish oil supplement

Control drug

Drug

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

Other names: Placebo drug

Primary outcomes

  1. Change in blood glucose from baseline

    Time frame: 12 months

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

  2. Change in blood lipids from baseline

    Time frame: 12 months

    The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.

  3. Change in carotid plaque and carotid intima-meida thickness

    Time frame: 12 months

    A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).

Secondary outcomes

  1. Change in gut microbiota from baseline

    Time frame: 12 months

    The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.

  2. Change in sleep quality

    Time frame: 12 months

    The investigators will measure the Pittsburgh Sleep Quality Index (PSQI) through face-to-face questionnaire before and after treatment. The PSQI ranges from 0 to 21, with a higher score indicating a worse sleep quality.

  3. Change in cognitive function

    Time frame: 12 months

    The investigators will do the mini-mental state examination (MMSE) before and after treatment. The MMSE score ranges from 0 to 30, with higher scores indicative of superior cognitive functioning.

  4. Change in bone mineral density (BMD)

    Time frame: 12 months

    The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the bone mineral density (BMD).

  5. Change in body fat distribution

    Time frame: 12 months

    The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the total and regional body fat mass (FM) and then percentages of regional body fat will be calculated.

  6. Change in urinary protein concentration

    Time frame: 12 months

    The investigators will collect urine sample from every participant and measure urinary protein before and after treatment.

  7. Change in estimated glomerular filtration rate (eGFR)

    Time frame: 12 months

    The investigators will collect blood sample from every participant and measure blood creatinine before and after treatment. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation will be used to calculate the eGFR.

  8. Change in blood metabolome

    Time frame: 12 months

    The investigators will collect blood samples from every participant and the UPLC-MS/MS method will be used to analyze the blood metabolomics profile.

Other outcomes

  1. Change in fecal metabolome

    Time frame: 12 months

    The investigators will collect fecal samples from every participant and the UPLC-MS/MS method will be used to analyze the fecal metabolomics profile.

  2. Change in urine metabolome

    Time frame: 12 months

    The investigators will collect urine samples from every participant and the UPLC-MS/MS method will be used to analyze the urine metabolomics profile.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2018
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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