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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Joudi k. Shaker, MSc
- Telefonnummer: +964-780-630-0739
- E-Mail: j.shaker@utq.edu.iq
Studienorte
-
-
TQ
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Nasiriyah, TQ, Irak, 64001
- Al Nasiriya Teaching Hospital
-
Kontakt:
- Joudi Shaker, MSc
- Telefonnummer: +9647806300739
- E-Mail: j.shaker@utq.edu.iq
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Adenosine Triphosphate (ATP) Concentration
Zeitfenster: 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. |
Baseline and immediately after the 10-to-20-minute light therapy session
|
|
Change in Cytochrome c Oxidase Activity
Zeitfenster: 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. |
Baseline and immediately after the 10-to-20-minute light therapy session
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Malondialdehyde (MDA) Levels
Zeitfenster: 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. |
Baseline and immediately after the 10-to-20-minute light therapy session
|
|
Change in Lactate and Pyruvate Concentrations
Zeitfenster: 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. |
Baseline and immediately after the 10 to 20-minute light therapy session
|
|
Change in Glutathione (GSH) Levels
Zeitfenster: Baseline and immediately after the 10-to-20-minute light therapy session
|
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
Zeitfenster: 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. |
Baseline and immediately after the 10-to-20-minute light therapy session
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Hattf B. Farhood, PhD, University of Thi-Qar
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UOTQ-SCI-2026-001
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Zeitrahmen
Data will become available immediately following the publication of the study results and will remain accessible for 5 years.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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