Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07047248

Acronym

PBM

Enrollment

Registered

2025-07-02

Start date

2025-08-30

Completion date

2026-01-30

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Mellitus

Brief summary

The development of an integral and global treatment to improve the quality of life in those withType II Diabetes Patients is challenging, thus a whole body Photobiomodulation (PBM) therapy program is proposed as an effective option.

Interventions

DEVICEPBM

A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes

OTHERPlacebo PBM

A placebo whole body red light will be carried out during 20 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Triple (ParticipantCare ProviderOutcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Adults aged 30 to 70 years. * Diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the American Diabetes Association (ADA) criteria. * HbA1c levels between 6.5% and 10% at screening. * Stable diabetes management regimen (medications and lifestyle) for at least three months prior to enrollment

Exclusion criteria

* Presence of severe diabetic complications (e.g., end-stage renal disease, proliferative diabetic retinopathy). * History of photosensitivity or medical conditions exacerbated by light exposure. * Use of medications or supplements known to significantly alter glucose metabolism, other than current stable diabetes management. * Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame	Description
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.	Follow-ups at 3 months and 6 months post-intervention	• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.

Secondary

Measure	Time frame	Description
Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).	Follow-ups at 3 months and 6 months post-intervention	The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026