Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Malaga
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Triple (ParticipantCare ProviderOutcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
intervention
A treatment with whole body red light therapy (NovoTHOR®) will be carried out
Intervention: PBM (Device)
Placebo
A placebo whole body red light will be carried out
Intervention: Placebo PBM (Other)
Outcomes
Primary Outcomes
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
Time Frame: Follow-ups at 3 months and 6 months post-intervention
• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
Secondary Outcomes
- Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).(Follow-ups at 3 months and 6 months post-intervention)
- Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).(Follow-ups at 3 months and 6 months post-intervention)
Investigators
Daniel Aguilar Nunez
danunez
University of Malaga