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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorUniversity of Malaga

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PBM

    Device

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

  • Placebo PBM

    Other intervention

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.

• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.

Time frame
Follow-ups at 3 months and 6 months post-intervention

Secondary outcomes

1

Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).

The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.

Time frame
Follow-ups at 3 months and 6 months post-intervention

Other outcomes

Sponsors and contacts

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University of Malaga

Lead sponsor

clinical professor

Collaborator

This trial is not recruiting at the moment. You can still explore other options: