The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients (PBM-T1D)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Red and Near-Infrared Light Therapy Pad

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joudi k. Shaker, MSc; Phone Number: +964-780-630-0739; Email: j.shaker@utq.edu.iq

Study Locations

• Iraq
  • TQ
    • Nasiriyah, TQ, Iraq, 64001
      • Al Nasiriya Teaching Hospital
      • Contact: Joudi Shaker, MSc; Phone Number: +9647806300739; Email: j.shaker@utq.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).
• Diabetes duration of at least 1 year (patient 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Photobiomodulation Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Malondialdehyde (MDA) Levels	Researchers quantify MDA concentration in the collected blood samples to assess oxidative stress.	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.	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.	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.	Baseline and immediately after the 10-to-20-minute light therapy session

Collaborators and Investigators

• Sponsor: University of Thi-Qar
• Investigators: Study Director: Hattf B. Farhood, PhD, University of Thi-Qar

Study record dates

Study Major Dates

• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): October 16, 2026
• Last Update Submitted That Met QC Criteria: October 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Oxidative Stress; Malondialdehyde; Mitochondria; Photobiomodulation; Glutathione; Low-Level Light Therapy; Adenosine Triphosphate; Cytochrome c Oxidase
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: UOTQ-SCI-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available immediately following the publication of the study results and will remain accessible for 5 years.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No