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

NCT ID: NCT07047248

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2026-01-30

Brief Summary

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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

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Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Triple (ParticipantCare ProviderOutcomes Assessor)

Study Groups

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intervention

A treatment with whole body red light therapy (NovoTHOR®) will be carried out

Group Type EXPERIMENTAL

PBM

Intervention Type DEVICE

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

Placebo

A placebo whole body red light will be carried out

Group Type PLACEBO_COMPARATOR

Placebo PBM

Intervention Type OTHER

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

Interventions

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PBM

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

Intervention Type DEVICE

Placebo PBM

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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clinical professor

UNKNOWN

Sponsor Role collaborator

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Daniel Aguilar Nunez

danunez

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PBM

Identifier Type: -

Identifier Source: org_study_id

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