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

NCT07833865 | Not Yet Recruiting

• 1 other identifier: UOTQ-SCI-2026-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Diabetes Mellitus Type 1

Keywords

Photobiomodulation; Malondialdehyde; Glutathione; Mitochondria; Cytochrome c Oxidase; Adenosine Triphosphate; Oxidative Stress; Low-Level Light Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Adenosine Triphosphate (ATP) Concentration

  Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.

  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.

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

Secondary Outcomes (4)

• Change in Malondialdehyde (MDA) Levels

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

• Change in Lactate and Pyruvate Concentrations

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

• Change in Glutathione (GSH) Levels

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

• Change in Blood Glucose Levels

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

Study Arms (1)

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.

Device: Red and Near-Infrared Light Therapy Pad

Interventions

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.

Photobiomodulation Intervention

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thi-Qar: lead

Study Sites (1)

Thi-Qar Specialized Diabetes, Endocrine and Metabolism Center (TDEMC)

Nasiriyah, TQ, 64001, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hattf B. Farhood, PhD

  University of Thi-Qar

  STUDY DIRECTOR

Central Study Contacts

Joudi k. Shaker, MSc

CONTACT

+964-780-630-0739; j.shaker@utq.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Researcher

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

IR (1)