Study aim

Dose

Term

Case

Endpoints and major findings

Ref.

To assess the effects of n-3 PUFAs on insulin concentration and lipid profiles among pregnant women with DM.

120 mg DHA and 180 mg EPA

6 wks.

28 gestational diabetic patients and 28 placebo controls.

No effect on fasting blood glucose and triglyceride. Decrease insulin, insulin resistance.

[78]

To investigate the effects of n-3 PUFAs on the cardiovascular biomarker and lipid profile parameters.

1 g fish oil

3 mos.

36 T2DM with cardiac autonomic neuropathy patients: 21 receiving fish oil and 15 receiving placebo.

Decrease N-terminal pro-brain natriuretic peptide, triglyceride and HDL cholesterol. No effect on LDL cholesterol.

[79]

To investigate whether n-3 PUFAs would change the fatty acids profile of the cerebro spinal fluid.

430 mg DHA and 150 mg EPA

6 mos.

33 mild Alzheimer’s disease patients: 18 receiving n-3 PUFA supplement and 15 receiving placebo.

Increase n-3 PUFAs concentration of the cerebrospinal fluid. Decrease total and phosphorylated tau protein of the cerebrospinal fluid.

[7]

To investigate whether n-3 PUFAs would ameliorate the adipose tissue inflammation.

4 g n-3 PUFA ethyl esters

3 mos.

33 patients: 19 receiving n-3 PUFA tablet and 14 receiving placebo.

Decrease MCP-1 and triglyceride.

No effect on adiponectin, IL-6 TNF-α, HDL cholesterol and LDL cholesterol.

[60]

To investigate the effects of n-3 PUFAs on inflammatory gene expression in the duodenum.

3 g DHA and EPA

2 mos.

12 patients (mean age 54.1 y, BMI 33.7).

No effects on inflammatory gene expression such as IL-6, TNF-α, IL-18 and STAT3.

[62]

To investigate the effect of n-3 PUFAs on nerve structure and function in T1DM (Whether n-3 PUFAs prevents or limits nerve damage in T1DM).

375 mg EPA, 280 mg DPA and 510 mg DHA

12 mos.

T1DM patients. Both gender. Age 18 y and older.

On going. Phase II

Estimated primary completion data: January 2015. Change in corneal nerve fibre length.

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To test whether vitamin D3 and/or EPA + DHA supplementation reduces the risk of T2D and improves insulin sensitivity.

465 mg EPA, 375 mg DHA and/or vitamin D3

T2DM patients. Both gender. Age 50 y and older.

On going.

Estimated primary completion data: October 2017. Measure insulin sensitivity, beta-cell function and HbA1c levels.

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To investigate the effects of n-3 PUFAs on atherothrombotic biomarkers in T2DM and Cardiovascular Disease.

1000 mg EPA and 1000 mg DHA

T2DM patients (HbA1c > 6.5%) with cardiovascular disease.

On going.

Estimated primary completion data: April 2015. Change insulin sensitivity, fasting glucose and HbA1c levels.

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To examine the effects of n-3 PUFAs on fasting insulin, glucose, insulin sensitivity in Chinese T2DM patients.

4 g fish oil (1200 mg EPA and 800 mg DHA)

6 mos.

240 T2DM patients: fasting glucose between 7.0 - 14.0 mmol/L, HbA1c < 9%, male, age 40 - 80 y.

On going.

Estimated primary completion data: December 2014.

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To investigate whether aspirin versus placebo and/or supplementation with n-3 PUFAs or placebo prevents the serious vascular events.

1 g n-3 PUFAs ethyl esters and/or 100 mg aspirin

T1DM and T2DM patients, age > 40 y, without previous history of vascular disease.

On going. Phase IV

Estimated primary completion data: December 2016.

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