Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
PBM
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedStudy Start
First participant enrolled
August 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedJuly 2, 2025
June 1, 2025
1 month
June 15, 2025
June 27, 2025
Conditions
Outcome Measures
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.
Follow-ups at 3 months and 6 months post-intervention
Secondary Outcomes (1)
Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).
Follow-ups at 3 months and 6 months post-intervention
Study Arms (2)
intervention
EXPERIMENTALA treatment with whole body red light therapy (NovoTHOR®) will be carried out
Placebo
PLACEBO COMPARATORA placebo whole body red light will be carried out
Interventions
A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Malagalead
- clinical professorcollaborator
Study Sites (1)
Dr
Granada, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Triple (ParticipantCare ProviderOutcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- danunez
Study Record Dates
First Submitted
June 15, 2025
First Posted
July 2, 2025
Study Start
August 30, 2025
Primary Completion
September 30, 2025
Study Completion
January 30, 2026
Last Updated
July 2, 2025
Record last verified: 2025-06