Protocol summary

Study aim
Determination of the effect of alpha lipoic acid supplementation on serum level of lipoprotein-dependent phospholipase A2 and related inflammatory and oxidative stress markers in type 2 diabetic patients
Design
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Clinical trial
Settings and conduct
Patients with type 2 diabetes who come to the Diabetes Clinic of Tehran University of Medical Sciences who have inclusion criteria will be included in the study. These patients will be randomized into two intervention and control groups for 2 months. The supplement and placebo are named by a third person in two forms A and B, and the researcher, analyst, and participants will be unaware of this categorization.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Willingness to cooperate; Age between 40-60 years old; Body mass index (BMI) between 18.5 to 29.9; At least 2 years of diagnosed type 2 diabetes; Controlled Diabetes (HbA1C <7%). Non-inclusion criteria: Taking Insulin; History of angina, myocardial infarction, and stroke, as well as other chronic diseases and infectious diseases in the past year; Tobacco and alcohol consumption in the last three months; Changes in treatment protocols in the last three months; taking any medicine other than metformin, glibenclamide, statin drugs, ACEI, ARB and doses less than 80 mg aspirin; Regular use of herbal Supplements containing antioxidants and omega-3 in the last three months (at least once a week); Pregnancy and lactation
Intervention groups
Patients in the intervention group received 1200 mg of alpha-lipoic acid supplement per day, and in the control group received placebo capsules (maltodextrin) for 2 months.
Main outcome variables
Lp-PLA2 and its lipoprotein distribution, ICAM-1, VCAM-1, TNF-a, IL-6, 8-isoproprane, and OX-LDL and APO A1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180407039219N1
Registration date: 2018-04-27, 1397/02/07
Registration timing: prospective

Last update: 2018-04-27, 1397/02/07
Update count: 0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Nima Baziar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
n-baziar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of alpha lipoic acid supplementation on serum level of LP-PLA2, it`s distribution between HDL and apo B containing lipoproteins and related oxidative stress and inflammatory markers in type 2 diabetic patients
Public title
Investigating the effect of alpha lipoic acid supplementation on oxidative stress and inflammatory markers in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate Age between 40-60 years old Body mass index (BMI) between 18.5 to 29.9 At least 2 years of diagnosed type 2 diabetes Controlled diabetes (HbA1C < 7%)
Exclusion criteria:
Taking insulin History of angina, myocardial infarction, and stroke, as well as other chronic diseases including liver disease, gastrointestinal disease, kidney disease, malignant disease, thyroid disease and other chronic and infectious diseases in the past year Tobacco and alcohol consumption in the last three months Changes in treatment protocols in the last three months Taking any medicine other than metformin, glibenclamide, statin drugs, ACEI, ARB and doses less than 80 mg aspirin Regular use of herbal Supplements containing antioxidants and omega-3 in the last three months (at least once a week) Pregnancy and lactation
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, diabetic patients will be randomly (block randomization) assigned to two intervention and control groups based on sex and menopausal (stratified randomization). We will create four blocks of letters T (treatment) and C (control), such that half the letters of each block T and the other half C (eg TTCC, CTTC, etc.). The blocks will be created and numbered then we will randomly select the blocks needed to reach the sample size and we will put them together. Based on the created pattern, patients will be assigned to two intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The supplements and placebos are similar in terms of shape, odor, taste, and packaging, and are labeled by a third person (from experts in the diabetes clinic) in two forms A and B.Patients, researcher and analyst would not know who was receiving the supplements and who was receiving a placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4583

Health conditions studied

1

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

Primary outcomes

1

Description
Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

2

Description
Lipoprotein-associated phospholipase A2 distribution among lipoproteins
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

3

Description
ICAM-1
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

4

Description
VCAM-1
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

5

Description
TNF-a
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

6

Description
Interleukin 6
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

7

Description
8-Isoprostane
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

8

Description
OX-LDL
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

9

Description
Apolipoprotein A1
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

Secondary outcomes

1

Description
Glucose
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Photometric assay

2

Description
Insuline
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay

3

Description
Total cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic assay

4

Description
HDL Cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic assay

5

Description
LDL Cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Friedewald formula

6

Description
Triglyceride
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic assay

Intervention groups

1

Description
Intervention group: The patients in the intervention group will receive 1200 mg daily of alpha-lipoic acid supplements in the form of two 600 mg capsules and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months. Supplements will be provided by Karen critical pharmaceutical and nutritional supplements company.
Category
Treatment - Drugs

2

Description
Control group: The patients in the control group will receive two placebo capsules (maltodextrin) and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months.Placebo capsules will be provided by Karen critical pharmaceutical and nutritional supplements company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes & Metabolic Diseases Clinic of Tehran University of Medical Sciences
Full name of responsible person
Nima Baziar
Street address
Next to the Emergency of Heart Center, Shahrivar St., North Kargar St.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8833 4192
Email
n-baziar@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. saeed Hosseini
Street address
Qods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8163 3698
Email
Hosseinis@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Saeed Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No 44, Hojjatdoust alley, Naderi St., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5569
Email
Hosseinis@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Saeed Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No 44, Hojjatdoust alley, Naderi St., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5569
Email
Hosseinis@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Baziar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No.44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Fax
Email
n-baziar@razi.tums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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