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

University of Malaga

Status: Not yet enrolling

Conditions: Type II Diabetes Mellitus

Treatments: Device: PBM; Other: Placebo PBM

Study type: Interventional

Funder types: Other

Identifiers

NCT07047248

PBM

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

intervention

Experimental group

Description:

A treatment with whole body red light therapy (NovoTHOR®) will be carried out

Treatment:

Device: PBM

Placebo

Placebo Comparator group

Description:

A placebo whole body red light will be carried out

Treatment:

Other: Placebo PBM