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The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient

Primary Purpose

Diabetes Mellitus Type II

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
n-3 Fatty Acid
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus Type II focused on measuring n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • willingness to participation,
  • diabetic patients 30- 60 years old,
  • body mass index in the range 25-40,
  • avoidance of dietary supplements,
  • vitamins and herbal products at least 3 months before and throughout the intervention

Exclusion Criteria:

  • people who have used n-3 Fatty Acid Supplementation in last 3 months,
  • having chronic renal disease ,
  • GI disease,
  • Hepatobiliary diseases,
  • hematological disorders,
  • hypo- or hyperthyroidism,
  • type 1 diabetes,
  • treatment with orlistat or sibutramine for weight loss,
  • pregnancy and lactation,
  • treatment with insulin or Thiazolidinediones.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    n-3 Fatty Acid Supplemetation

    Placebo

    Arm Description

    patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.

    patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.

    Outcomes

    Primary Outcome Measures

    Serum Fasting Blood Sugar(FBS)

    Secondary Outcome Measures

    Serum Insulin
    Serum HbA1C
    Serum Resistin
    Serum adiponectin
    Serum mcp-1
    Gene Expression of AdipoR1
    Gene Expression of AdipoR2
    Gene Expression of Sirt-1
    Beck depression score
    Serum cholesterol
    Serum LDL cholesterol
    Serum TG
    Serum HDL cholesterol

    Full Information

    First Posted
    October 7, 2014
    Last Updated
    November 17, 2015
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02261545
    Brief Title
    The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient
    Official Title
    The Effect of n-3 Fatty Acid Supplementation on the Expression of Sirt-1, Adiponectin Receptor 1 (AdipoR1) & Adiponectin Receptor 2 (AdipoR2) Genes of PBMC and Circulatory Levels of Resistin,Monocyte Chemotactic Protein (MCP-1) and Adiponectin of type2 Diabetes Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to determine the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of type2 diabetes patient
    Detailed Description
    The aim of this study is to determine of the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) & AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled, 88 men and women 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 , 24-hour food recall for 3 days and beck depression questionnaire 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. The supplement group, will receive mg 1800mg EPA(Eicosapentaenoic acid ) & 900mg DHA( docosahexaenoic acid) (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700 mg 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 12 hours fasting and anthropometric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus Type II
    Keywords
    n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    n-3 Fatty Acid Supplemetation
    Arm Type
    Active Comparator
    Arm Description
    patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    n-3 Fatty Acid
    Other Intervention Name(s)
    omega-3, n-3 PUFA
    Intervention Description
    n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.
    Primary Outcome Measure Information:
    Title
    Serum Fasting Blood Sugar(FBS)
    Time Frame
    Change from baseline at 10 weeks
    Secondary Outcome Measure Information:
    Title
    Serum Insulin
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum HbA1C
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum Resistin
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum adiponectin
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum mcp-1
    Time Frame
    Change from baseline at 10 weeks
    Title
    Gene Expression of AdipoR1
    Time Frame
    Change from baseline at 10 weeks
    Title
    Gene Expression of AdipoR2
    Time Frame
    Change from baseline at 10 weeks
    Title
    Gene Expression of Sirt-1
    Time Frame
    Change from baseline at 10 weeks
    Title
    Beck depression score
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum cholesterol
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum LDL cholesterol
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum TG
    Time Frame
    Change from baseline at 10 weeks
    Title
    Serum HDL cholesterol
    Time Frame
    Change from baseline at 10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 25-40, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention Exclusion Criteria: people who have used n-3 Fatty Acid Supplementation in last 3 months, having chronic renal disease , GI disease, Hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, type 1 diabetes, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29900143
    Citation
    Mazaherioun M, Saedisomeolia A, Javanbakht MH, Koohdani F, Zarei M, Ansari S, Khoshkhoo Bazargani F, Djalali M. Long Chain n-3 Fatty Acids Improve Depression Syndrome in Type 2 Diabetes Mellitus. Iran J Public Health. 2018 Apr;47(4):575-583.
    Results Reference
    derived

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    The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient

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