Protocol summary

Summary
Objective: The effect of omega 3 fatty acids supplementation in adult with type 2 of diabetes mellitus Study design Randomized, double-blind, placebo-controlled, single-center, trial study (phase II) population: Adults with Type 2 Diabetes Referring to the Iranian Diabetes Center inclusion criteria: 30-65 years of age, T2DM diagnosis, and BMI in the range of 18.5 to 40 kg/m2 exclusion criteria: Unwillingness to cooperate, change the dose or type of anti-diabetes drug, incidence of any sensitivity Interventions: omega 3 supplementation and placebo Intervention period: 10 weeks outcomes: plasma levels of omentin, chemerin and TNF-a

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092724081N3
Registration date: 2017-11-01, 1396/08/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Niaz Mohammadzade Honarvar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4461
Email address
honarvar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assesment of the effects of omega 3 faty acid supplementation on serum level of Omentin , Chemerin and TNF-alpha in patients with type 2 diabetes mellitus
Public title
The effects of omega-3 fatty acids supplementation on type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
The criteria for inclusion were as follows: 30-65 years of age; T2DM diagnosis; and BMI in the range of 18.5 to 40 kg/m2. Patients with a history of diseases including chronic renal; hepatic; gastrointestinal; hematological diseases; and thyroid disorder as well as pregnant and lactating patients were excluded from the study. Furthermore, Patients who were treated with insulin; Thiazolidinediones or consumed weight loss drugs and any nutritional supplement 2 weeks prior to the beginning of the study were excluded from the study. The exclusion criteria: Unwillingness to cooperate; change the dose or type of anti-diabetes drug; incidence of any sensitivity Interventions.
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Tehran university of medical sciences
Street address
16 azar St., Keshavarz Blvd
City
Tehran
Postal code
1366736511
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
IR.TUMS.REC.1394.1989

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
omentin
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
ELISA - mg/dl

2

Description
chemerin
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
ELISA - mg/dl

3

Description
TNF-alpha
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
ELISA - pg/dl

Secondary outcomes

1

Description
Insulin
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
ELISA/µIU/ml

2

Description
HOMA-IR
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
fasting insulin (μIU/ml) × fasting glucose (mmol/ml)/22.5

3

Description
QUICKI
Timepoint
Pre-intervention/10 weeks after intervention
Method of measurement
1/{log[fasting insulin (μU/mL)] + log[fasting glucose (mg/dL)]

Intervention groups

1

Description
Intervention group: four softgels of ω-3 per day, containing 310 mg EPA, 210 mg DHA, 110 mg other polyunsaturated fatty acids and five mg vitamin E
Category
Treatment - Drugs

2

Description
Control group: four placebo softgels a day, containing paraffin oil with the same size and color as ω-3 fatty acid soft gels
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetic Association
Full name of responsible person
Mohammad prohan
Street address
Number27,Ramin Malekoti alley,Patris street, Satarkhan streeet
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr.younesian
Street address
Sixth Floor, Central Department of University, Ghods St., Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niaz Mohammadzade Honarva
Position
Assistant professor/PhD Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition and Dietetic, Hojat doost Alley, Naderi St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4461
Fax
Email
honarvar@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niaz Mohammadzade Honarvar
Position
PhD Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition and Dietetic, Hojat doost Alley, Naderi St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4461
Fax
Email
honarvar@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niaz Mohammadzade Honarvar
Position
Assistant professor/PhD Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition and Dietetic, Hojat doost Alley, Naderi St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4461
Fax
Email
honarvar@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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