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NCT Number: NCT07047248

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

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr

Granada, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBM

Device

A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes

Placebo PBM

Other

A placebo whole body red light will be carried out during 20 minutes

Primary outcomes

  1. 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

  1. Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • clinical professor

Registry information

Acronym: PBM

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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