HealthyPBM-T1DNCT07833865
The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients
A study testing Red and Near-Infrared Light Therapy Pad in people with Healthy and Diabetes Mellitus Type 1, run by University of Thi-Qar at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate the effects of low-level light therapy on cellular energy and oxidative stress in healthy adults and patients with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Diabetes Mellitus Type 1
- What is being tested?
- Red and Near-Infrared Light Therapy Pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 13 Oct 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12 to 40 years.
- Confirmed diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association criteria (patient group).
- Insulin dependence (patient group).
- Low serum C-peptide levels (patient group).
- Fasting plasma glucose concentration <100 mg/dL (healthy control group).
- Glycated haemoglobin (HbA1c) <5.7% (healthy control group).
- Diabetes duration of at least 1 year (patient group).
Who cannot join
- Diabetic ketoacidosis within the preceding month.
- High-sensitivity C-reactive protein (hs-CRP) >10 mg/L or active infection.
- Renal insufficiency.
- Liver disease.
- Pregnancy.
- Smoking.
Show all 9Show fewer
- Use of antioxidant supplements, vitamin C, or vitamin E within the preceding month.
- Autoimmune diseases other than Type 1 Diabetes Mellitus.
- Haematological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Al Nasiriya Teaching Hospital
Nasiriyah, TQ, 64001
Joudi Shaker, MSc, +9647806300739, j.shaker@utq.edu.iq
About this study
Official title: Biochemical Study of Metabolic Regulation and Extraction of Mitochondrial Biomarkers in Type 1 Diabetes Mellitus in Thi-Qar Governorate, Iraq
The goal of this clinical trial is to evaluate the effects of low-level light therapy on cellular energy and oxidative stress in healthy adults and patients with Type 1 diabetes. The main questions it aims to answer are:
Does light therapy change adenosine triphosphate (ATP) levels and cytochrome c oxidase activity in blood cells? How does the intervention affect oxidative stress markers, specifically glutathione and malondialdehyde concentrations? Researchers will compare blood samples collected before the light therapy to those collected afterward to see if the intervention alters mitochondrial function. Researchers will also compare the responses of healthy volunteers to those of diabetic patients.
Read more
Participants will:
Provide a baseline blood sample. Receive red and near-infrared light exposure (660 nm and 850 nm) on their arms for 10 to 20 minutes using a therapy pad.
Provide a final blood sample immediately after the light exposure.
Read the detailed description
This study evaluates the metabolic effects of photobiomodulation on peripheral blood mononuclear cells in patients with Type 1 diabetes and healthy volunteers. The intervention applies red (660 nm) and near-infrared (850 nm) light to stimulate cytochrome c oxidase within the mitochondrial electron transport chain. This photon absorption increases cellular respiration and alters oxidative stress markers.
Researchers collect baseline venous blood samples from all participants to establish initial biochemical parameters. The clinical team isolates peripheral blood mononuclear cells using density gradient centrifugation. Following baseline collection, participants receive a single 10-to-20-minute light therapy session on the upper arm using a flexible light pad. Researchers collect a second venous blood sample immediately after the light exposure.
The laboratory analysis quantifies specific mitochondrial and metabolic variables in the cell lysates before and after the intervention. The primary metrics are adenosine triphosphate (ATP) concentration and cytochrome c oxidase specific activity. Secondary measures include malondialdehyde and glutathione to assess lipid peroxidation and antioxidant capacity. The research team also measures lactate and pyruvate levels to evaluate shifts in cellular glycolysis, alongside standard fasting plasma glucose monitoring. The comparative analysis evaluates differences in metabolic response between the diabetic cohort and the healthy matched controls.
- Conditions
- Healthy, Diabetes Mellitus Type 1
- Being tested
- Red and Near-Infrared Light Therapy Pad
- Keywords
- Photobiomodulation, Malondialdehyde, Glutathione, Mitochondria, Cytochrome c Oxidase, Adenosine Triphosphate, Oxidative Stress, Low-Level Light Therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red and Near-Infrared Light Therapy PadDevice
Participants receive a single photobiomodulation session using a flexible light therapy pad. The device delivers red light at 660 nm and near-infrared light at 850 nm with an operating voltage of 5V and a working current of 1.7A. The pad is placed in direct contact with the upper arm of each participant for a timed duration of 10 to 20 minutes. Researchers evaluate cellular responses before and immediately after this single application.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Intervention | Experimental | Researchers apply the photobiomodulation device to the arm of every enrolled participant, encompassing both the healthy volunteers and the patients diagnosed with Type 1 diabetes, for a strictly timed session lasting between 10 and 20 minutes. Receives: Device: Red and Near-Infrared Light Therapy Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adenosine Triphosphate (ATP) Concentration
Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.
Measured: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Cytochrome c Oxidase Activity
Researchers assess the specific activity of cytochrome c oxidase in blood samples via a biochemical assay to determine mitochondrial function.
Measured: Baseline and immediately after the 10-to-20-minute light therapy session
Secondary outcomes (4)
Change in Malondialdehyde (MDA) Levels
Researchers quantify MDA concentration in the collected blood samples to assess oxidative stress.
Measured: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Lactate and Pyruvate Concentrations
Researchers determine the concentrations of lactate and pyruvate in blood cells to analyze metabolic shifts.
Measured: Baseline and immediately after the 10 to 20-minute light therapy session
Change in Glutathione (GSH) Levels
Researchers measure glutathione concentration in the blood samples to evaluate antioxidant capacity.
Measured: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Blood Glucose Levels
Researchers measure blood glucose concentrations in the collected blood samples to evaluate glycemic changes following the light therapy session.
Measured: Baseline and immediately after the 10-to-20-minute light therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start13 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study assigns all participants, encompassing Type 1 Diabetes patients and healthy volunteers, to a single group receiving the identical photobiomodulation intervention. Researchers expose the participants to red and near-infrared light for 10 to 20 minutes. The resulting biochemical data is stratified during the statistical analysis phase to evaluate and compare the responses between the two cohorts.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thi-Qar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joudi Shaker, University of Thi-Qar
- Investigators
- Hattf B. Farhood, PhD, Study director, University of Thi-Qar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833865
- Sponsor's protocol ID
- UOTQ-SCI-2026-001
- Acronym
- PBM-T1D
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie the results reported in the published article will be shared after complete de-identification. This includes demographic characteristics and all measured biochemical variables (ATP concentration, cytochrome c oxidase activity, malondialdehyde, glutathione, lactate, pyruvate, and blood glucose) collected at baseline and immediately following the light therapy session.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Study of Metabolic Regulation and Extraction of Mitochondrial Biomarkers in Type 1 Diabetes Mellitus in Thi-Qar Governorate, Iraq
- ClinicalTrials.gov ID
- NCT07833865
- Acronym / sponsor ID
- PBM-T1D / UOTQ-SCI-2026-001
- Conditions
- Healthy, Diabetes Mellitus Type 1
- Keywords
- Photobiomodulation, Malondialdehyde, Glutathione, Mitochondria, Cytochrome c Oxidase, Adenosine Triphosphate, Oxidative Stress, Low-Level Light Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Thi-QarUniversity, hospital or other
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 22 Sep 2026 (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 evaluate the effects of low-level light therapy on cellular energy and oxidative stress in healthy adults and patients with Type 1 diabetes. The main questions it aims to answer are:
Does light therapy change adenosine triphosphate (ATP) levels and cytochrome c oxidase activity in blood cells? How does the intervention affect oxidative stress markers, specifically glutathione and malondialdehyde concentrations? Researchers will compare blood samples collected before the light therapy to those collected afterward to see if the intervention alters mitochondrial function. Researchers will also compare the responses of healthy volunteers to those of diabetic patients.
Participants will:
Provide a baseline blood sample. Receive red and near-infrared light exposure (660 nm and 850 nm) on their arms for 10 to 20 minutes using a therapy pad.
Provide a final blood sample immediately after the light exposure.
Detailed description
This study evaluates the metabolic effects of photobiomodulation on peripheral blood mononuclear cells in patients with Type 1 diabetes and healthy volunteers. The intervention applies red (660 nm) and near-infrared (850 nm) light to stimulate cytochrome c oxidase within the mitochondrial electron transport chain. This photon absorption increases cellular respiration and alters oxidative stress markers.
Researchers collect baseline venous blood samples from all participants to establish initial biochemical parameters. The clinical team isolates peripheral blood mononuclear cells using density gradient centrifugation. Following baseline collection, participants receive a single 10-to-20-minute light therapy session on the upper arm using a flexible light pad. Researchers collect a second venous blood sample immediately after the light exposure.
The laboratory analysis quantifies specific mitochondrial and metabolic variables in the cell lysates before and after the intervention. The primary metrics are adenosine triphosphate (ATP) concentration and cytochrome c oxidase specific activity. Secondary measures include malondialdehyde and glutathione to assess lipid peroxidation and antioxidant capacity. The research team also measures lactate and pyruvate levels to evaluate shifts in cellular glycolysis, alongside standard fasting plasma glucose monitoring. The comparative analysis evaluates differences in metabolic response between the diabetic cohort and the healthy matched controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study assigns all participants, encompassing Type 1 Diabetes patients and healthy volunteers, to a single group receiving the identical photobiomodulation intervention. Researchers expose the participants to red and near-infrared light for 10 to 20 minutes. The resulting biochemical data is stratified during the statistical analysis phase to evaluate and compare the responses between the two cohorts.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Intervention | Experimental | Device: Red and Near-Infrared Light Therapy PadResearchers apply the photobiomodulation device to the arm of every enrolled participant, encompassing both the healthy volunteers and the patients diagnosed with Type 1 diabetes, for a strictly timed session lasting between 10 and 20 minutes. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 12 to 40 years.
- Confirmed diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association criteria (patient group).
- Insulin dependence (patient group).
- Low serum C-peptide levels (patient group).
- Fasting plasma glucose concentration <100 mg/dL (healthy control group).
Key exclusion criteria (9 listed)
- Diabetic ketoacidosis within the preceding month.
- High-sensitivity C-reactive protein (hs-CRP) >10 mg/L or active infection.
- Renal insufficiency.
- Liver disease.
- Pregnancy.
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 |
|---|---|---|
| Red and Near-Infrared Light Therapy PadParticipants receive a single photobiomodulation session using a flexible light therapy pad. The device delivers red light at 660 nm and near-infrared light at 850 nm with an operating voltage of 5V and a working current of 1.7A. The pad is placed in direct contact with the upper arm of each participant for a timed duration of 10 to 20 minutes. Researchers evaluate cellular responses before and immediately after this single application. | Device | Photobiomodulation Intervention |
Primary outcome
Change in Adenosine Triphosphate (ATP) Concentration
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.
Change in Cytochrome c Oxidase Activity
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Researchers assess the specific activity of cytochrome c oxidase in blood samples via a biochemical assay to determine mitochondrial function.
4 secondary outcomes
Change in Malondialdehyde (MDA) Levels
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Lactate and Pyruvate Concentrations
Time frame: Baseline and immediately after the 10 to 20-minute light therapy session
Change in Glutathione (GSH) Levels
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Blood Glucose Levels
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie the results reported in the published article will be shared after complete de-identification. This includes demographic characteristics and all measured biochemical variables (ATP concentration, cytochrome c oxidase activity, malondialdehyde, glutathione, lactate, pyruvate, and blood glucose) collected at baseline and immediately following the light therapy session.
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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.
Hattf B. Farhood, PhD study director
University of Thi-Qar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red and Near-Infrared Light Therapy Pad in people with Healthy and Diabetes Mellitus Type 1, run by University of Thi-Qar at 1 site in Iraq.
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 7 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joudi k. Shaker, MSc (+964-780-630-0739, j.shaker@utq.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adenosine Triphosphate (ATP) Concentration (time frame: Baseline and immediately after the 10-to-20-minute light therapy session). The study lists 2 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 16 Oct 2026.