Type II Diabetes MellitusPBMNCT07047248
Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
A study testing PBM in people with Type II Diabetes Mellitus, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- PBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 30 Aug 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- PBM, Placebo PBM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMDevice
A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes
Placebo PBMOther
A placebo whole body red light will be carried out during 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | A treatment with whole body red light therapy (NovoTHOR®) will be carried out Receives: Device: PBM |
| Placebo | Placebo comparator | A placebo whole body red light will be carried out Receives: Other: Placebo PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
- Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
Measured: Follow-ups at 3 months and 6 months post-intervention
Secondary outcomes (1)
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.
Measured: Follow-ups at 3 months and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- clinical professor
- Responsible party
- Principal investigator, Daniel Aguilar Nunez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047248
- Sponsor's protocol ID
- PBM
- Acronym
- PBM
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07047248
- Acronym / sponsor ID
- PBM / PBM
- Conditions
- Type II Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- clinical professor
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: PBMA treatment with whole body red light therapy (NovoTHOR®) will be carried out |
| Placebo | Placebo comparator | Other: Placebo PBMA placebo whole body red light will be carried out |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBMA whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes | Device | intervention |
| Placebo PBMA placebo whole body red light will be carried out during 20 minutes | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Follow-ups at 3 months and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM in people with Type II Diabetes Mellitus, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c. (time frame: Follow-ups at 3 months and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.