Diabete Type 2NCT05845190
Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients
A study testing aerobic exercises and resistance exercises in people with Diabete Type 2, run by Egyptian Chinese University at 1 site in Egypt.
Trial summary
The goal of this [clinical trial] is to [ compare ] in [ diabetic male patients ]. The main question to answer is : Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients? Participants will take their medications and… Read more about this study
- Who is it for?
- Ages 40 to 55 years, men only
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- aerobic exercises and resistance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 1- Their ages will range from 40 -55 years 2- Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites.
- Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge. (Punthakee et al.,2018).
- All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled.
- 4- All patients are medically and psychologically stable
Who cannot join
- Patients with uncontrolled blood glucose level
- Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study.
- Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease).
- Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis).
- Patients with BMI > 35 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this [clinical trial] is to [ compare ] in [ diabetic male patients ]. The main question to answer is :
Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients?
Participants will take their medications and group of them do aerobic exercises and another group do resistance training
Read the detailed description
40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients.
The patients will be randomly assigned to two equal (in number) groups:
Group (A) Twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks.
Group (B) Twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.
- Conditions
- Diabete Type 2
- Being tested
- aerobic exercises, resistance exercises
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercisesOther
Also called group A
aerobic exercises in form of walking on treadmill
resistance exercisesOther
Also called group B
60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercises group (group A ) | Experimental | 20 male patients with diabetes mellites Attended the program of walking on treadmill for 12 weeks according to the following parameters.
Exercise prescription:
Intensity: started by 60-75% of target heart rate according to each patient response.
Duration: Each session consisted of five minutes warming up firstly then 25-30 minutes time of session ended by five minutes cool down exercises Frequency: Three times / week (day after day) for 12 weeks Receives: Other: aerobic exercises |
| resistance exercises group (group B) | Experimental | 20 male patients with diabetes mellites will participate in resistance training exercises 30-45 mins. The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise) with initial load of 60% of 1 repetition maximum.
This program consists of 3 sets of 8 to 12 repetitions, then increasing load when subject was able to complete 12 repetitions. A rest period of 1.5 min was established between each set.
Mode: 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 leg exercises (leg press, extension, and flexion), abdominal crunches and back extensions. with the individualized workloads at 60% of 1RM.
Duration: 30 min-45 min (total session). Frequency: Three times / week (day after day). Intensity: increased load was established when subject was able to complete 12 repetitions. Receives: Other: resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
homocystiene
Homocysteine was measured with an enzyme linked immunosorbent (ELISA) method. The upper limit of normal is 15 μmol/l
Measured: 12 weeks of training
Secondary outcomes (2)
insulin
normal value <25 mlu/L fasting
Measured: 12 weeks of training
cholestrol
Desirable cholesterol levels are considered to be those below 200 mg/dL in adults
Measured: 12 weeks of trianing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start4 Apr 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- simple randomization using a randomization table created by a computer software program
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Chinese University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanan hassan, Egyptian Chinese University
- Investigators
- hanan hassan, Principal investigator, Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845190
- Sponsor's protocol ID
- P.T.REC/012/003654
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of the individual participant data collected during the trail, after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05845190
- Acronym / sponsor ID
- P.T.REC/012/003654
- Conditions
- Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Egyptian Chinese UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this [clinical trial] is to [ compare ] in [ diabetic male patients ]. The main question to answer is :
Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients?
Participants will take their medications and group of them do aerobic exercises and another group do resistance training
Detailed description
40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients.
The patients will be randomly assigned to two equal (in number) groups:
Group (A) Twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks.
Group (B) Twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- simple randomization using a randomization table created by a computer software program
| Arm | Type | Receives |
|---|---|---|
| aerobic exercises group (group A ) | Experimental | Other: aerobic exercises20 male patients with diabetes mellites Attended the program of walking on treadmill for 12 weeks according to the following parameters. Exercise prescription: Intensity: started by 60-75% of target heart rate according to each patient response. Duration: Each session consisted of five minutes warming up firstly then 25-30 minutes time of session ended by five minutes cool down exercises Frequency: Three times / week (day after day) for 12 weeks |
| resistance exercises group (group B) | Experimental | Other: resistance exercises20 male patients with diabetes mellites will participate in resistance training exercises 30-45 mins. The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise) with initial load of 60% of 1 repetition maximum. This program consists of 3 sets of 8 to 12 repetitions, then increasing load when subject was able to complete 12 repetitions. A rest period of 1.5 min was established between each set. Mode: 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 leg exercises (leg press, extension, and flexion), abdominal crunches and back extensions. with the individualized workloads at 60% of 1RM. Duration: 30 min-45 min (total session). Frequency: Three times / week (day after day). Intensity: increased load was established when subject was able to complete 12 repetitions. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1- Their ages will range from 40 -55 years 2- Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites.
- Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge. (Punthakee et al.,2018).
- All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled.
- 4- All patients are medically and psychologically stable
Key exclusion criteria (5 listed)
- Patients with uncontrolled blood glucose level
- Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study.
- Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease).
- Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis).
- Patients with BMI > 35 will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercisesAlso: group Aaerobic exercises in form of walking on treadmill | Other | aerobic exercises group (group A ) |
| resistance exercisesAlso: group B60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions | Other | resistance exercises group (group B) |
Primary outcome
homocystiene
Time frame: 12 weeks of training
Homocysteine was measured with an enzyme linked immunosorbent (ELISA) method. The upper limit of normal is 15 μmol/l
2 secondary outcomes
insulin
Time frame: 12 weeks of training
cholestrol
Time frame: 12 weeks of trianing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Yes. all of the individual participant data collected during the trail, after de-identification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hanan hassan principal investigator
Egyptian Chinese University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercises and resistance exercises in people with Diabete Type 2, run by Egyptian Chinese University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
homocystiene (time frame: 12 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.