Type 2 Diabetes Mellitus (T2DM)Phase 2LLLTNCT06827171
Impact of LLL and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
A Phase 2 study testing aerobic exercise + low-level laser therapy and Aerobic exercise in people with Type 2 Diabetes Mellitus (T2DM), run by Nouran Hesham Slama Younis at 1 site in Egypt.
Trial summary
Diabetes is one of the fastest-growing diseases worldwide, It has Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy, and neuropathy) In Egypt, factors in patients that affect diabetic control include the patient's… Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- aerobic exercise + low-level laser therapy and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 30 Jun 2025
- Phase
- Phase 2
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Their ages will range from 55- 65 years, for both genders.
- Body Mass Index of 25-29.9kg/m2.
- Glycated hemoglobin (HbA1c) from 7 to 9 %.
- The patient has suffered from diabetes for more than 5 years.
- Patient with mild to moderate PAD on Rutherford classification stages (1-3)
Who cannot join
- Patients with a history of hypo-hyperglycemic coma.
- Uncontrolled cardiovascular complications, and ischemic heart disease.
- Photosensitivity, Malignancy, Anemia, Hemorrhagic diseases (contraindication to laser)
- Deep venous thrombosis, acute thromboses.
- Cerebrovascular disease.
- Patients with Monckeberg sclerosis.
Show all 9Show fewer
- Patient with resting pain critical limb ischemia, diabetic foot, and peripheral edema, asymptomatic PAD, Diabetic neuropathy.
- Patient with minor/ or major amputations.
- A patient with positive smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Diabetes is one of the fastest-growing diseases worldwide, It has Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy, and neuropathy) In Egypt, factors in patients that affect diabetic control include the patient's education and occupation and smoking status. Physical exercise is important for diabetes control. Metformin and investigation availability have a positive association with diabetes control.
Diabetes mellitus increases the risk and accelerates the course of peripheral artery disease, making patients more susceptible to ischemic events and infections and delaying tissue healing. The current understanding of pathogenic mechanisms is mainly based on the negative influence of diabetes mellitus on atherosclerotic disease and inflammation (Fadini et al., 2020).) An early diagnosis of peripheral arterial diseases PAD and correctly identifying patients with Chronic limb-threatening ischemia CLTI are crucial in patients with diabetes to improve outcomes.
Read more
Several treatment strategies can be subdivided into lifestyle modification, medical management, endovascular therapies, and surgical interventions for the treatment of PAD.
Exercise training improves walking ability, distances, physical function, and vitality. Physical activity by supervised exercise is recommended in first-line therapy for intermittent claudication by SVS, ESVS, and AHA (Treat-Jacobson et al., 219) More specifically, a supervised exercise program consists of walking a minimum of three times per week (30-60 min/session) for at least 12 weeks Therapeutic laser treatment, also known as low-level laser therapy (LLLT), offers numerous benefits. It is non-surgical, promotes tissue healing, and reduces edema, inflammation, and pain.
Read the detailed description
The participants will be submitted into two equal groups in numbers:
Group A (Study group) n=20 will receive a low-level laser (scanning laser) combined with an aerobic exercise program for 12 weeks (3 sessions/ week).
Group B (control group) n=20: Who will receive aerobic exercise for 12 weeks (3sessions/week) All patients with their prescribed medications (hypoglycemic, antiplatelet, anticoagulants, antihypertensive, vasodilators, analgesics)
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- aerobic exercise + low-level laser therapy, Aerobic exercise
- Keywords
- Peripheral artery Disease, Low level laser, Aerobic exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise + low-level laser therapyCombination product
low- level laser parameters: The wavelength: 808 +/- 5nm The power: output is 450 Mw Type of beam: red laser beam. Beam Divergent >,025 rad+/- ,005rad Nominal Distance of Sight hazard >8m The duration: is 20 min for each artery. Treatment period: 3 times/week for 3 months.
Aerobic exerciseOther
Aerobic exercise Frequency = 3sessions/week duration: 10 min warm up and 10 min cool down/ 30 min stance phase Intensity: moderate intensity initiating with 50% HR max to end 75% HR max
| Study group | Role | What they receive |
|---|---|---|
| Study group A: Aerobic exercise+ low-level Laser therapy | Experimental | (Study group A): It will receive a low-level laser (scanning laser) on the course of the posterior tibial and anterior tibial artery combined with an aerobic exercise program for peripheral artery disorder for 12 weeks (3 sessions/ week). Receives: Combination Product: aerobic exercise + low-level laser therapy; Other: Aerobic exercise |
| Control group B: Aerobic Exercise group B | Experimental | group B: They will receive aerobic exercise for 12 weeks. aerobic exercise program for peripheral arterial disorders and intermittent claudication. Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
Body mass index (Kg/M^2): by dividing the weight by kilogram over Height by meter square.
Measured: 3 month
peak systolic velocities (PSV)
Duplex ultrasonography of the lower extremity arteries, from common femoral to pedal arteries is used to measure PSV
- Peak systolic velocities (PSV) were recorded in meters per second (Ugwu et al., 2021).
- The normal peak systolic velocity (PSV) in peripheral lower limb arteries varies from 45-180 cm/s (Abdelrahman, 2010).
Severe arterial disease manifests as a PSV over 200 cm/s, monophasic waveform, and spectral broadening of the Doppler waveform.
Measured: 3 months
Ankle-Brachial Index (ABI) %
- Ankle-Brachial Index (ABI) is a ratio of the highest ankle systolic blood pressure obtained in the anterior tibial/ dorsalis pedis or posterior tibial artery to that of the highest brachial systolic pressure.
An ABI < 0.9 was diagnostic of PAD and values were stratified according to severity as:
- 0.7-0.89 = mild arterial obstruction.
- 0.5-0.69 = moderate arterial obstruction.
- ≤ 0.5 = severe arterial obstruction.
Measured: 3 months
The visual analog scale (VAS) questionnaire for pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Delgado etal., 2018).
- no pain (0-4 mm)
- mild pain(5-44 mm)
- moderate pain (45-74 mm)
- severe pain (75-100 mm). (Weigl K et al., 2021)
Measured: 3 months
The Edinburgh Claudication Questionnaire (ECQ)
The Edinburgh Claudication Questionnaire (ECQ) Definition of positive classification requires all of the following responses: \Yes" to (1), \No" to (2), \Yes" to (3), Grade 1 \No" to (4), and Grade 2 \Yes" to (4). If these criteria are met, a typical claudicant is one who indicates the pain is in the calf, regardless of whether the pain is also marked at other sites; a diagnosis of atypical claudication is made when the pain is marked in the thigh or buttock, in the absence of any calf pain. Subjects should not be diagnosed with claudication if the pain is indicated in the hamstrings, feet, shins, and joints, or radiates in the absence of any calf pain
Measured: 3 months
Secondary outcomes (2)
The initial claudication distance and The absolute claudication distance (meters)
The initial claudication distance (ICD), or pain-free walking distance; is the distance walked at the onset of claudication pain The absolute claudication distance (ACD), or maximal walking distance at which claudication pain becomes so severe that the patient is forced to stop (Jongert et al., 2003)
Measured: 3 months
Maximum oxygen consumption Vo^2 max ((ml/kg/min))
depend on Modified Bruce protocol with the treadmill. Modified Bruce protocol, the first stage at 1.7mph and 0% grade second stage at 1.7 mph 5% grade, and the third stage at 1.7 mph and 10% grade.
The test score is the time taken on the test, in minutes. This can also be converted to an estimated VO2 max score using the calculator below and the following formulas, where the value "T" is the total time completed (expressed in minutes and fractions of a minute e.g. 9 minutes 25 seconds = 9.25 minutes).
Men : VO2max (ml/kg/min) = 14.76 -(1.379 × T) + (0.451 × T²)-(0.012 × T³) Women: VO2max (ml/kg/min) = 4.38x T -3.9 (ACSM, 2023)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the study is going to contain 2 experimental groups, the first one will receive combined therapy (aerobic exercise program for PAD + low-level laser therapy) the other group will receive aerobic exercise program for PAD only.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nouran Hesham Slama Younis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nouran Hesham Slama Younis, Cairo University
- Investigators
- Nesreen Gh EL NAHAS, doctor, Principal investigator, head of physical therapy department for internal medicine, Cairo university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827171
- Sponsor's protocol ID
- P.T.REC/012/004935
- Acronym
- LLLT
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06827171
- Acronym / sponsor ID
- LLLT / P.T.REC/012/004935
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Peripheral artery Disease, Low level laser, Aerobic exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nouran Hesham Slama YounisUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 14 Feb 2025 (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.
Diabetes is one of the fastest-growing diseases worldwide, It has Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy, and neuropathy) In Egypt, factors in patients that affect diabetic control include the patient's education and occupation and smoking status. Physical exercise is important for diabetes control. Metformin and investigation availability have a positive association with diabetes control.
Diabetes mellitus increases the risk and accelerates the course of peripheral artery disease, making patients more susceptible to ischemic events and infections and delaying tissue healing. The current understanding of pathogenic mechanisms is mainly based on the negative influence of diabetes mellitus on atherosclerotic disease and inflammation (Fadini et al., 2020).) An early diagnosis of peripheral arterial diseases PAD and correctly identifying patients with Chronic limb-threatening ischemia CLTI are crucial in patients with diabetes to improve outcomes.
Several treatment strategies can be subdivided into lifestyle modification, medical management, endovascular therapies, and surgical interventions for the treatment of PAD.
Exercise training improves walking ability, distances, physical function, and vitality. Physical activity by supervised exercise is recommended in first-line therapy for intermittent claudication by SVS, ESVS, and AHA (Treat-Jacobson et al., 219) More specifically, a supervised exercise program consists of walking a minimum of three times per week (30-60 min/session) for at least 12 weeks Therapeutic laser treatment, also known as low-level laser therapy (LLLT), offers numerous benefits. It is non-surgical, promotes tissue healing, and reduces edema, inflammation, and pain.
Detailed description
The participants will be submitted into two equal groups in numbers:
Group A (Study group) n=20 will receive a low-level laser (scanning laser) combined with an aerobic exercise program for 12 weeks (3 sessions/ week).
Group B (control group) n=20: Who will receive aerobic exercise for 12 weeks (3sessions/week) All patients with their prescribed medications (hypoglycemic, antiplatelet, anticoagulants, antihypertensive, vasodilators, analgesics)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- the study is going to contain 2 experimental groups, the first one will receive combined therapy (aerobic exercise program for PAD + low-level laser therapy) the other group will receive aerobic exercise program for PAD only.
| Arm | Type | Receives |
|---|---|---|
| Study group A: Aerobic exercise+ low-level Laser therapy | Experimental | Combination Product: aerobic exercise + low-level laser therapy, Other: Aerobic exercise(Study group A): It will receive a low-level laser (scanning laser) on the course of the posterior tibial and anterior tibial artery combined with an aerobic exercise program for peripheral artery disorder for 12 weeks (3 sessions/ week). |
| Control group B: Aerobic Exercise group B | Experimental | Other: Aerobic exercisegroup B: They will receive aerobic exercise for 12 weeks. aerobic exercise program for peripheral arterial disorders and intermittent claudication. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Their ages will range from 55- 65 years, for both genders.
- Body Mass Index of 25-29.9kg/m2.
- Glycated hemoglobin (HbA1c) from 7 to 9 %.
- The patient has suffered from diabetes for more than 5 years.
- Patient with mild to moderate PAD on Rutherford classification stages (1-3)
Key exclusion criteria (9 listed)
- Patients with a history of hypo-hyperglycemic coma.
- Uncontrolled cardiovascular complications, and ischemic heart disease.
- Photosensitivity, Malignancy, Anemia, Hemorrhagic diseases (contraindication to laser)
- Deep venous thrombosis, acute thromboses.
- Cerebrovascular disease.
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 exercise + low-level laser therapylow- level laser parameters: The wavelength: 808 +/- 5nm The power: output is 450 Mw Type of beam: red laser beam. Beam Divergent >,025 rad+/- ,005rad Nominal Distance of Sight hazard >8m The duration: is 20 min for each artery. Treatment period: 3 times/week for 3 months. | Combination product | Study group A: Aerobic exercise+ low-level Laser therapy |
| Aerobic exerciseAerobic exercise Frequency = 3sessions/week duration: 10 min warm up and 10 min cool down/ 30 min stance phase Intensity: moderate intensity initiating with 50% HR max to end 75% HR max | Other | Control group B: Aerobic Exercise group B, Study group A: Aerobic exercise+ low-level Laser therapy |
Primary outcome
body mass index
Time frame: 3 month
Body mass index (Kg/M^2): by dividing the weight by kilogram over Height by meter square.
peak systolic velocities (PSV)
Time frame: 3 months
Duplex ultrasonography of the lower extremity arteries, from common femoral to pedal arteries is used to measure PSV * Peak systolic velocities (PSV) were recorded in meters per second (Ugwu et al., 2021). * The normal peak systolic velocity (PSV) in peripheral lower limb arteries varies from 45-180 cm/s (Abdelrahman, 2010). Severe arterial disease manifests as a PSV over 200 cm/s, monophasic waveform, and spectral broadening of the Doppler waveform.
Ankle-Brachial Index (ABI) %
Time frame: 3 months
• Ankle-Brachial Index (ABI) is a ratio of the highest ankle systolic blood pressure obtained in the anterior tibial/ dorsalis pedis or posterior tibial artery to that of the highest brachial systolic pressure. An ABI < 0.9 was diagnostic of PAD and values were stratified according to severity as: * 0.7-0.89 = mild arterial obstruction. * 0.5-0.69 = moderate arterial obstruction. * ≤ 0.5 = severe arterial obstruction.
The visual analog scale (VAS) questionnaire for pain
Time frame: 3 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Delgado etal., 2018). * no pain (0-4 mm) * mild pain(5-44 mm) * moderate pain (45-74 mm) * severe pain (75-100 mm). (Weigl K et al., 2021)
The Edinburgh Claudication Questionnaire (ECQ)
Time frame: 3 months
The Edinburgh Claudication Questionnaire (ECQ) Definition of positive classification requires all of the following responses: \Yes" to (1), \No" to (2), \Yes" to (3), Grade 1 \No" to (4), and Grade 2 \Yes" to (4). If these criteria are met, a typical claudicant is one who indicates the pain is in the calf, regardless of whether the pain is also marked at other sites; a diagnosis of atypical claudication is made when the pain is marked in the thigh or buttock, in the absence of any calf pain. Subjects should not be diagnosed with claudication if the pain is indicated in the hamstrings, feet, shins, and joints, or radiates in the absence of any calf pain
2 secondary outcomes
The initial claudication distance and The absolute claudication distance (meters)
Time frame: 3 months
Maximum oxygen consumption Vo^2 max ((ml/kg/min))
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Nesreen Gh EL NAHAS, doctor principal investigator
head of physical therapy department for internal medicine, Cairo university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aerobic exercise + low-level laser therapy and Aerobic exercise in people with Type 2 Diabetes Mellitus (T2DM), run by Nouran Hesham Slama Younis 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 19 Aug 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
body mass index (time frame: 3 month). The study lists 5 primary outcomes in all. 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 19 Aug 2025.