Not yet recruiting NCT07047248
Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PBM, Placebo PBM.
- Who it may be relevant to
- Registry conditions: Type II Diabetes Mellitus. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device PBM
A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes - Other Placebo PBM
A placebo whole body red light will be carried out during 20 minutes
Primary outcome measures
- 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 outcome measures (1)
- Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI). [Time frame: Follow-ups at 3 months and 6 months post-intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Dr — Granada
Identifiers
NCT: NCT07047248 · PBM