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AzTrials

Diabetes Mellitus Type IINCT03258840

EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus

A study testing EPA Supplement in people with Diabetes Mellitus Type II, run by Tehran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the… Read more about this study

Who is it for?
Ages 35 to 50 years
Conditions the study is for
Diabetes Mellitus Type II
What is being tested?
EPA Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteIran
Study dates
Jan 2013to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Willingness to collaborate in the study
  • aged 35-50 years
  • having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma glucose),
  • 25≤BMI<30 kg/m2

Who cannot join

  • pregnant and breastfeeding women
  • using insulin, alcohol consumption, smoking and other drugs
  • taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements
  • followers of the special diet
  • history of diabetic retinopathy or diabetic nephropathy
  • type 1 diabetes mellitus and other disorders
  • any need to take insulin, change in the dose (s) and type of medication or physical activity

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition

    Tehran, 1471613151

Other trials in Iran

About this study

Official title: The Effect of EPA on the Serum Activities of Paraoxonase 1, Homocystein, Thiolactonase and Some Indicators of Vascular Inflammation and PON2 Gene Expression in PBMC Ofthe Patients With Type II Diabetes

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.

Read the detailed description

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.

Being tested
EPA Supplement, EPA Placebo
Keywords
EPA, Paraoxonase 1, Paraoxonase 2, Type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPA SupplementDietary supplement

    Also called Eicosapentaenoic acid

    EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.

  • EPA PlaceboDietary supplement

    EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.

Study groups in NCT03258840
Study groupRoleWhat they receive
EPA placeboPlacebo comparatorEPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks
Receives: Dietary Supplement: EPA Placebo
EPA supplementActive comparatorEPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.
Receives: Dietary Supplement: EPA Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Hemoglobin A1c (HbA1c) measurement by related kits according their protocols

    Measured: Change from Baseline at 8 weeks after the intervention

Secondary outcomes (20)

  1. PON2 gene expression

    measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR

    Measured: Baseline, 8 weeks after the intervention

  2. Systolic blood pressure

    Systolic blood pressure changes measurement by manometer

    Measured: Change frome baseline at 8 weeks

  3. Diastolic blood pressure

    Diastolic blood pressure changes measurement by manometer

    Measured: Change frome baseline at 8 weeks

  4. serum paraoxonase-1(PON-1) activity

    serum paraoxonase-1(PON-1) activity by kit according related protocol

    Measured: Baseline, 8 weeks after the intervention

  5. PON1/HDL-c Ratio

    calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  6. serum paraoxonase lactonase (PON-HCTLase) activity

    measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  7. HDL-c

    high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  8. FBS

    Fasting blood sugar (FBS) measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  9. HDL2-c

    high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  10. HDL3-c

    high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  11. Serum apo B

    Serum apo-protein B measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  12. Serum apo A-I

    Serum apo-protein A-I measurement by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  13. apo B/apo A-I Ratio

    calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols

    Measured: Baseline, 8 weeks after the intervention

  14. Serum methionine

    measurement of serum levels of methionine by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  15. Serum malondialdehyde (MDA)

    measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  16. Serum homocysteine (Hcy)

    measurement of serum levels of homocysteine (Hcy) by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  17. Serum sE-Selectin

    measurement of serum levels of soluble E-Selectin by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  18. sVCAM-1

    measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  19. Serum cysteine

    measurement of serum levels of cysteine by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

  20. Serum Lpa

    measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol

    Measured: Baseline, 8 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study startJan 2013
  3. Primary completionApr 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258840
Sponsor's protocol ID
15202
Status last verified
Dec 2011
First submitted
16 Jul 2017
Last updated
23 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Golzari MH, Javanbakht MH, Ghaedi E, Mohammadi H, Djalali M. Effect of Eicosapentaenoic Acid Supplementation on Paraoxonase 2 Gene Expression in Patients with Type 2 Diabetes Mellitus: a Randomized Double-blind Clinical Trial. Clin Nutr Res. 2019 Jan 28;8(1):17-27. doi: 10.7762/cnr.2019.8.1.17. eCollection 2019 Jan.

    PubMed 30746344

Questions about this trial

What is this clinical trial studying?

A study testing EPA Supplement in people with Diabetes Mellitus Type II, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Change from Baseline at 8 weeks after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03258840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.

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