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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
PBM
DeviceA whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes
Placebo PBM
Other interventionA placebo whole body red light will be carried out during 20 minutes
Treatment groups
Trial outcomes
Primary outcomes
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
Secondary outcomes
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.
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: