Aim of research: review the effect of eight weeks of aerobic training with silymarin consumption on glycemic indices and liver enzymes in men with type 2 diabetes
Design
Study population of all male diabetic patients in Gachsaran city with 3 years history of diabetes who volunteered to participate in the study and randomly divided into 4 groups.
Settings and conduct
T Initially, a notice was issued to notify all diabetic patients associations; announcements were issued to notify all patients with type 2 diabetes all over Gachsaran city. Then, in a briefing session, the potential risks and benefits of participating in the present study were explained to all participants. to make them unable to do physical activity were selected.all subjects competed the consent form.Subjects were randomly divided into 4 groups, including: (1) control + placebo (2) aerobic training + placebo (coated tablet containing wheat flour) (3) aerobic training + silymarin supplementation, and (4) silymarin consumption.Silymarin receiving groups consumed coated tablets containing 140 mg / kg silymarin daily (one after breakfast and one after dinner) by the Livergol brand manufactured by GolDarou Company (economic code IRC12280250372)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diabetic history of 3 years or more،Age 40 to 50 years؛
Exclusion criteria:Special diseases like hypertension; Smoking; Regular exercises in two last years
Intervention groups
The control group(1) did not exercise for 2 months and did not take silymarin.The aerobic training group (2) trained for eight weeks, three sessions per week and each session for 20-45 minutes with an intensity of 60 to 85% of the stored heart rate.The silymarin group (3) consumes two 140 mg silicone-coated tablets daily.Aerobic Exercise + Silymarin (4) group exercise for 2 months and use Silymarin tablets.
Main outcome variables
Glucose; insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046506N1
Registration date:2020-02-27, 1398/12/08
Registration timing:retrospective
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Ali Khajehlandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 5910
Email address
a.khajehlandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of aerobic training with silymarin consumption on glycemic indices and liver enzymes in men with type 2 diabetes
Public title
The effect of eight weeks of aerobic training with silymarin consumption on glycemic indices and liver enzymes in men with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients who have had a minimum of 3 years of diabetes
Age of participants 40 - 50 years
Exclusion criteria:
The lack having the effects of diabetes, like diabetic foot ulcers
The lack history of heart disease and lung disease
The lack regular exercise of athletic activity in the last two years
The lack of tobacco in the last six months
Age
From 40 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to four groups, Excel software is used as follows:
First, a list of participants is compiled and we assign each participant a specific number using the RAW function, then randomly select each participant using the RANDBETWEEN and VLOOKUP functions and assign them to each participant. We assign 4 groups to groups. The first, second, third and fourth subjects were assigned to the control group, aerobic exercise group, silymarin supplementation group, and aerobic training + silymarin group, respectively. Others are assigned to groups in the same way.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University ,Gachsaran Branch
Street address
Daneshjo Blvd.,Gachsaran
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
63876-75818
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.IAU.IAUG.REC.1398.006
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glucose
Timepoint
Two months after intervention
Method of measurement
Blood serum
Secondary outcomes
1
Description
Weight Lose
Timepoint
Two months after training
Method of measurement
by Scale
Intervention groups
1
Description
Intervention group: Three sessions of exercise per week and each session 20-45 minutes with intensity of 60 to 85% of heart rate reserve, for eight weeks
Category
Other
2
Description
Intervention group: Use silymarin for 8 weeks daily in two coats of 140 mg silicarin coated tablets (one after breakfast and one after dinner) with the Lever Flower brand manufactured by Gul Daroo Company (economic code IRC12280250372).
Category
Other
3
Description
Intervention group: Three sessions of exercise per week, each session of 20-45 minutes, with 60-85% heart rate reserve plus silymarin for 8 weeks daily, two 140 mg silicarin-coated tablets (one after breakfast and one with breakfast). After Dinner) By Liver Flower brand made by Gol Daroo Company (economic code IRC12280250372)
Category
Other
4
Description
Control group: Take a coated tablet containing wheat flour
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Gachcaran Branch
Full name of responsible person
ALI Khajehlandi
Street address
No.12, North Tenth Ave., Valiasr Blvd., Gachsaran
City
Gachcaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797786
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
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, Islamic Azad University Gachsaran Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Khajehlandi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7517977836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD