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

Not Applicable

Not yet recruiting

• Conditions: Type II Diabetes Mellitus

• Registration Number: NCT07047248
• Lead Sponsor: University of Malaga

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Study Start: 2025-08-30
• Primary Completion: 2025-09-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.	Follow-ups at 3 months and 6 months post-intervention	• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).	Follow-ups at 3 months and 6 months post-intervention	The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.

Trial Locations

Locations (1)

Dr; 🇪🇸 Granada, Spain