An interventional study of Red and Near-Infrared Light Therapy Pad in Healthy and Diabetes Mellitus Type 1, sponsored by University of Thi-Qar. Not yet recruiting at 1 site in Iraq. Open to participants aged 12 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Thi-Qar · Not applicable, Interventional, and Basic science
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Thi-Qar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Red and Near-Infrared Light Therapy Pad
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.
Change in Adenosine Triphosphate (ATP) Concentration
Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.
Time frame: 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.
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Change in Malondialdehyde (MDA) Levels
Researchers quantify MDA concentration in the collected blood samples to assess oxidative stress.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and immediately after the 10-to-20-minute light therapy session
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will become available immediately following the publication of the study results and will remain accessible for 5 years.
Access criteria: Data and supporting documents will be available to academic researchers who submit a methodologically sound proposal. Requesters must outline the specific aims of their intended analysis, such as meta-analyses or secondary evaluations related to photobiomodulation and cellular metabolism. Requests should be sent directly to the corresponding author via email. The principal investigator and the academic supervisory committee at Thi-Qar University will review all requests. This process prevents data misuse. Upon approval, the research team will transmit the de-identified datasets securely to the requester.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 3 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Thi-Qar