Effects of Moderate-Intensity Exercise with Momordica Charantia L. on serum Glycemic indexes, reverse cholesterol transport elements and Lipocalins (RBP-4 and Lcn-2) in Men with Type 2 Diabetes
The aim of this study was to examine the Protective Effect of aerobic training along with Momordica charantia L on Hyperglycemia control indexes reverse cholesterol transport elements and Lipocalins (RBP-4 and Lcn-2) in man with type 2 diabetes.
Design
36 men with type 2 diabetes selected from Tehran and randomly divided into four groups (Control-Water, Control-Momordica charantia, Control-Training and Momordica charantia+Training). Training group’s perform Aerobic Training for for eight weeks, three sessions a week (40% to 70% of the reserved heart rate and for 15 to 45 min). Control-Momordica charantia and Momordica charantia+Training will feed 2000 mg of Momordica charantia for eight weeks (Twice a day before breakfast and dinner).
Settings and conduct
Intervention Research, Tehran City The location of the research is the Iran Football Medical Assessment and Rehabilitation Center (IFMARC ), which has already been coordinated. In this research, people who work with subjects are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 Diabetes; Not having regular physical activity; Without receive insulin Exclusion criteria: Have Heart and Kidney failure; Inability to Training; Have Musculoskeletal Disorders
Intervention groups
Aerobic Training and Momordica charantia L
Main outcome variables
Effect of aerobic training with Momordica charantia L on Hyperglycemia control indexes such as: GLP-1, DPP-4, GLP, Glucose, Insulin, Insulin resistance and APO-a1, APO-E, Lcn-2, RBP4
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161218031451N2
Registration date:2019-11-05, 1398/08/14
Registration timing:registered_while_recruiting
Last update:2019-11-05, 1398/08/14
Update count:0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Orod Mohajer Iravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2330 2233
Email address
o.iravani@petroiran.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Moderate-Intensity Exercise with Momordica Charantia L. on serum Glycemic indexes, reverse cholesterol transport elements and Lipocalins (RBP-4 and Lcn-2) in Men with Type 2 Diabetes
Public title
Effect of training and Momordica charantia L on diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 Diabetes
Not having regular physical activity
Without receive insulin
At least 45 years old
Exclusion criteria:
Have Heart and Kidney failure
Inability to Training
Have Musculoskeletal Disorders
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
9
Men with Type 2 Diabetes
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size, they will be equally divided into four groups (Control-Water, Control-Momordica charantia, Control-Training and Momordica charantia+Training).
Blinding (investigator's opinion)
Single blinded
Blinding description
The Control-Momordica charantia and Momordica charantia+Training patients receive Momordica charantia (2000 mg/day), two capsules orally of 500 mg twice daily before breakfast and dinner for 8 weeks. Control-Water and Control-Training groups receive placebo in the same pharmacological presentation. Starch is used as placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sport Sciences Research Institute of Iran
Street address
Motahari Ave., Miramad St., No. 5th Lane
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.008
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Effect of aerobic training and Momordica charantia L on GLP-1
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
2
Description
Effect of aerobic training and Momordica charantia L on GIP
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
3
Description
Effect of aerobic training and Momordica charantia L on DPP-4
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
4
Description
Effect of aerobic training and Momordica charantia L on Insulin Resistance
Timepoint
Before and after the protocol
Method of measurement
HOMA-IR METOD
5
Description
Effect of aerobic training and Momordica charantia L on APO-a1
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
6
Description
Effect of aerobic training and Momordica charantia L on APO-E
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
7
Description
Effect of aerobic training and Momordica charantia L on LCN-2
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
8
Description
Effect of aerobic training and Momordica charantia L on RBP4
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods
Secondary outcomes
empty
Intervention groups
1
Description
Control group: in this group we have not any intervention during 6 weeks, and will consider this group as placebo.
Category
Placebo
2
Description
Intervention group: Training group (in this group for six week, three session/weeks), the training start with 10 min warming and then 25 min training with 60 Vo2max, on go up to every day 2 min increase to the training time up 45 min until the end of intervention with 75 vo2 max).
Category
Treatment - Other
3
Description
Intervention group: Momordica charantia group (in this group eat 2000 mg of Momordica charantia for eight weeks Twice a day before breakfast and dinner).
Category
Treatment - Other
4
Description
Intervention group: Momordica charantia- Training group ( In this group the Simultaneous intervention, Momordica charantia and training, will treat with the same protocol that describe at the previous part).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Diabetes Association
Full name of responsible person
Ahmad Abdi
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
a.abdi@iauamol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asieeh Abbassi Daloii
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
abbasi.daloii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Full name of responsible person
Ahmad Abdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
a.abdi@iauamol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Barari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+1143217126
Email
alireza54.barari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Abdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
a.abdi@iauamol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The report is submitted to the research department of the university. Also published as a paper.
When the data will become available and for how long
Since 2020
To whom data/document is available
All researchers
Under which criteria data/document could be used
Citing references
From where data/document is obtainable
Scientific bases and Ayatollah Amoli Branch, Islamic Azad University, amol, Iran
What processes are involved for a request to access data/document