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Evaluating the effect of omega-3 and zinc oral supplementation on glycemic index, serum zinc levels, body composition and blood pressure in type 2 diabetic patients

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History
# Registration date Revision Id
2 2018-02-18, 1396/11/29 37675
1 2018-01-30, 1396/11/10 35243
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  • General information

    Not blinded
    Double blinded
    1
    1
    1
    empty
    Assignment to study group was done by a research team member, as the only non-blind person in our study. Other team members (including team leader and study coordinator), as well as all participants remained unaware of the allocations until the end of the study.
    empty
    اختصاص تصادفی از طریق یک لیست تخصیص تصادفی توسط یکی از اعضای تیم تحقیقاتی به عنوان تنها فرد غیر کور شده به تخصیص صورت گرفت. دیگر اعضای تیم تحقیقاتی (از جمله سرپرست تیم و هماهنگ کننده مطالعه (study coordinator)) و همچنین تمامی افراد شرکت کننده، به تخصیص تصادفی گروه ها و مداخله کور بودند و تا انتها ی مطالعه کور باقی ماندند.

  • Intervention groups

    #1
    Control group:Group D: In this study, people in the control group received one tablet of starch with a capsule containing Myglycol oil
    Receive one daily capsule of placebo containing starch
    گروه کنترل: گروه D= در این مطالعه افراد گروه کنترل روزانه یک عدد قرص نشاسته بهمراه یک عدد کپسول حاوی روغن میگلیول دریافت کنند
    گروه کنترل: گروه D= دریافت روزانه یک عدد کپسول پلاسبو حاوی نشاسته

  • Sponsors / Funding sources

    #1
    empty
    Yes
    Urmia University of Medical Sciences
    Oroumia University of Medical Sciences
    دانشگاه علوم پزشکی ارومیه
    دانشگاه علوم پزشکی ارومیه

Protocol summary

Study aim
Evaluating the effect of omega-3 and zinc oral supplementation on glycemic index, serum zinc levels, body composition and blood pressure in type 2 diabetic patients
Design
This study will be conducted as a randomized, parallel controlled clinical trial on 80 patients with type 2 diabetes.
Settings and conduct
This study will be performed as a randomized, parallel controlled clinical trial among patients with type 2 diabetes for 8 weeks.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: type 2 diabetes and age range older than 18 years Non-inclusion criteria: insulin infusion. kidney disease. Severe physical activity during the intervention
Intervention groups
Patients were randomly divided into 3 intervention groups including omega-3 (n = 20), zinc (n = 20), omega-3 and zinc (n = 20) and placebo groups (n = 20) with intervention group (n = 20)
Main outcome variables
Glycemic indexes, serum zinc level, body composition and blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170214032571N9
Registration date: 2018-01-30, 1396/11/10
Registration timing: retrospective

Last update: 2018-02-19, 1396/11/30
Update count: 1
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Majid Manafi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32770698
Email address
manafi.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-30, 1395/07/09
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of omega-3 and zinc oral supplementation on glycemic index, serum zinc levels, body composition and blood pressure in type 2 diabetic patients
Public title
The effect of supplementation of omega-3 and zinc on the treatment of type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range over 18 years old in both sexes Type 2 diabetes
Exclusion criteria:
Insulin injection Pregnancy and lactation Pancreatic cancer Severe physical activity during the intervention
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into 4 equal groups of 20 (A total of 80) by using simple randomization method. The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D).
Blinding (investigator's opinion)
Double blinded
Blinding description
Assignment to study group was done by a research team member, as the only non-blind person in our study. Other team members (including team leader and study coordinator), as well as all participants remained unaware of the allocations until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, orjans valley, Rresalat boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
Ir.Umsu.Rec.1395.371

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Weight
Timepoint
At weeks 0, 8
Method of measurement
Scale, Kg

2

Description
Body mass index
Timepoint
At weeks 0, 8
Method of measurement
Weight(kg) / Height(m)²

3

Description
Insulin resistance
Timepoint
At weeks 0, 8
Method of measurement
(fasting serum glucose (mmol/L) × fasting serum insulin (μIU/ml))/22.5

4

Description
Fasting Blood Sugar
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method, mg/dl

5

Description
Quantitative Insulin Sensitivity Check Index
Timepoint
At weeks 0, 8
Method of measurement
1/ [ log(fasting insulin, µU/ml) + log (fasting glucose, mg/dl) ]

6

Description
Serum insulin
Timepoint
At weeks 0, 8
Method of measurement
Radioimmunoassay

7

Description
Serum zinc
Timepoint
At weeks 0, 8
Method of measurement
Colorimetric

8

Description
Systolic blood pressure
Timepoint
At weeks 0, 8
Method of measurement
Mercury pressure gauge, Mm mercury

9

Description
Diastolic blood pressure
Timepoint
At weeks 0, 8
Method of measurement
Mercury pressure gauge, Mm mercury

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A = Intervention with omega-3 at a dose of 1000 mg daily one number capsule for 8 weeks - Dana Pharmaceutical Company
Category
Treatment - Drugs

2

Description
Intervention group: Intervention with zinc at a dose of 30 mg daily One number tablet for 8 weeks - Dine Pharmaceutical Company
Category
Treatment - Drugs

3

Description
Intervention group: Intervention with omega-3 at a dose of 1000 mg plus zinc at a dose of 30 mg daily for 8 weeks
Category
Treatment - Drugs

4

Description
Receive one daily capsule of placebo containing starch
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Urmia
Full name of responsible person
Dr. Peyvand Mohammadi
Street address
Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3223 7601
Fax
+98 44 3278 0801
Email
majidmanafi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebi
Street address
Orjhans street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
majidmanafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Fax
+98 44 1278 0803
Email
majidmanafi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Fax
+98 44 1278 0803
Email
majidmanafi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Manafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road Urmia West Azarbijan Iran, Islamic Republic Of
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Fax
+98 44 1278 0803
Email
majidmanafi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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