The effect of 8 weeks of combined exercises and consumption of nettle extract on some renal indicators, lipid profile, insulin resistance in people with high blood pressure and type 2 diabetes
Determining the effect of 8 weeks of combined exercises and consumption of nettle extract on some renal indicators, lipid profile, insulin resistance in people with high blood pressure and type 2 diabetes.
Design
Clinical trial with control group, with parallel groups, randomized, on 40 patients. Randomization by the method of equal blocks (10 blocks of 4) in which a number of intervention people and a number of comparison people are included in each block.
Settings and conduct
By referring to the clinic and health network of Yangi Imam town located in Alborz province, eligible people were identified and placed in the intervention groups using equal blocks randomization (10 blocks of 4). Then, people will go to the sports club for training intervention and perform exercises and supplements for 8 weeks. And before and 24 hours after exercise interventions, blood samples are taken from people to be measured in the laboratory.
Participants/Inclusion and exclusion criteria
Entry requirements: type 2 diabetes
Conditions of non-entry: inability to practice
Intervention groups
Group of combined and complementary exercises: in the group of combined exercises, the samples perform aerobic and resistance exercises, and the supplementary groups also consume nettle extract. The control group is not subjected to any intervention.
Main outcome variables
High blood pressure, lipid profile (triglycerides, cholesterol, etc.) and insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056548N4
Registration date:2023-02-27, 1401/12/08
Registration timing:prospective
Last update:2023-02-27, 1401/12/08
Update count:0
Registration date
2023-02-27, 1401/12/08
Registrant information
Name
saeid shamlou kazemi
Name of organization / entity
Bu-Ali Sina university
Country
Iran (Islamic Republic of)
Phone
+98 81 3221 0929
Email address
saeidshamlou9092@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-03-10, 1401/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of combined exercises and consumption of nettle extract on some renal indicators, lipid profile, insulin resistance in people with high blood pressure and type 2 diabetes
Public title
The effect of exercise and nettle extract on type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from type 2 diabetes
Exclusion criteria:
History of cardiovascular disease
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomization, the method of equal blocks (10 blocks of 4) was used, in which a number of intervention people and a number of comparison people are included in each block, and we assigned them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.
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 Sport Sciences Research Institute
Street address
Fifth Alley, Mir Emad Ave., Ostad Motahari Ave
City
Tehran
Province
Tehran
Postal code
1474674646
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.SSRI.REC.1401.1576
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
The percentage of people whose blood pressure decreased.
Timepoint
Measurement before and after the intervention
Method of measurement
Using a mercury pressure gauge (ALPK2) made in Japan
2
Description
The percentage of people whose cholesterol, low-density lipoprotein and triglyceride levels have decreased.
Timepoint
Measurement before and after the intervention
Method of measurement
By testing blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the group of combined exercises (resistance-aerobic), training was about 180-190 minutes per week, 30 minutes of aerobic training and 30-40 minutes of resistance training in 3 sessions per week. In the initial sessions, after a 10-minute warm-up program, the participants walk on a treadmill for 20 minutes with an intensity of 60-70% of the maximum heart rate. In order to determine the intensity of the exercise, the maximum heart rate is calculated using the age-220 formula. After aerobic training, 5 minutes rest and then resistance training is done. In the first session, the resistance training is for getting to know and learning the correct movements, the subjects do the first week with minimal weight and a few repetitions below the maximum. From the second week onwards, after estimating the one repetition maximum (1RM). Resistance training is performed with an intensity equivalent to 60 percent of a maximum repetition with 10 repetitions per movement for 3 consecutive sets of 30 seconds rest between each station and 120 seconds rest between each round. These exercises are programmed in 10 circular movements. Stations include: chest press, shoulder press (military), underarm lat, leg press, front thigh, lying back thigh, leg pull, front arm and back arm pull-up and sit-up. It is deadlift and squat. 5 minutes are allocated for cooling down. In order to comply with the principle of overload and increase the intensity, once every 2 weeks, a maximum repetition is re-measured and 60% of it is calculated. The intervention of extract consumption in supplement and exercise + supplement groups is carried out 15 minutes before the three main meals of breakfast, lunch and dinner and daily for eight weeks. According to previous studies, the dose of nettle was considered to be 10 grams per day, and 10 grams will be divided into three parts and consumed as an extract. Nettle extract will be prepared from the essential plant pharmaceutical company.
Category
Treatment - Other
2
Description
Control group: They are not subject to any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yangi Imam clinic and health network
Full name of responsible person
Saeid Shamlou Kazemi
Street address
Yengi Imam town
City
Karaj
Province
Alborz
Postal code
3149915968
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Danesh Alborz University
Full name of responsible person
Saeid Shamlou Kazemi
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Danesh Alborz University
Proportion provided by this source
10
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
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the intellectual rights are preserved, the data can be sent to the researchers.
From where data/document is obtainable
Email address: saeidshamlou9092@gmail.com
What processes are involved for a request to access data/document