About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Diabetic ketoacidosis within the preceding month.
High-sensitivity C-reactive protein (hs-CRP) >10 mg/L or active infection.
Renal insufficiency.
Liver disease.
Trial design
Single group
Treatments tested in this trial
Red and Near-Infrared Light Therapy Pad
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Adenosine Triphosphate (ATP) Concentration
Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.
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.
Secondary outcomes
Change in Malondialdehyde (MDA) Levels
Researchers quantify MDA concentration in the collected blood samples to assess oxidative stress.
Change in Lactate and Pyruvate Concentrations
Researchers determine the concentrations of lactate and pyruvate in blood cells to analyze metabolic shifts.
Change in Glutathione (GSH) Levels
Researchers measure glutathione concentration in the blood samples to evaluate antioxidant capacity.
Change in Blood Glucose Levels
Researchers measure blood glucose concentrations in the collected blood samples to evaluate glycemic changes following the light therapy session.
Sponsors and contacts
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