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NCT Number: NCT07833865

The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients

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.

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Key information

Conditions

Healthy Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus Type 1 Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Use of antioxidant supplements, vitamin C, or vitamin E within the preceding month.
  • Autoimmune diseases other than Type 1 Diabetes Mellitus.
  • Haematological disorders.

Treatment and study plan

Red and Near-Infrared Light Therapy Pad

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Malondialdehyde (MDA) Levels

    Time frame: Baseline and immediately after the 10-to-20-minute light therapy session

    Researchers quantify MDA concentration in the collected blood samples to assess oxidative stress.

  2. Change in Lactate and Pyruvate Concentrations

    Time frame: Baseline and immediately after the 10 to 20-minute light therapy session

    Researchers determine the concentrations of lactate and pyruvate in blood cells to analyze metabolic shifts.

  3. Change in Glutathione (GSH) Levels

    Time frame: Baseline and immediately after the 10-to-20-minute light therapy session

    Researchers measure glutathione concentration in the blood samples to evaluate antioxidant capacity.

  4. Change in Blood Glucose Levels

    Time frame: Baseline and immediately after the 10-to-20-minute light therapy session

    Researchers measure blood glucose concentrations in the collected blood samples to evaluate glycemic changes following the light therapy session.

Study contacts

Contact information is provided by the study sponsor or research team.

Joudi k. Shaker, BSc

CONTACT

[email protected]

+964-780-630-0739

Sponsors and collaborators

Lead sponsor

University of Thi-Qar

Other

Registry information

Official study title

Biochemical Study of Metabolic Regulation and Extraction of Mitochondrial Biomarkers in Type 1 Diabetes Mellitus in Thi-Qar Governorate, Iraq

Acronym: PBM-T1D

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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