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Effects of Phototherapy on Diabetes Mellitus and Control of Cardiac Function

Effects of Photobiomodulation on Diabetes Mellitus and Cardiac Autonomic Control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-38wn44
Enrollment
Unknown
Registered
2018-02-21
Start date
2017-04-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-insulin-dependent diabetes mellitus

Interventions

Ten volunteers with a clinical diagnosis of DM2 participated in the study. All volunteers were randomly submitted (raffle with opaque envelope) to 6 sessions of photobiomodulation (PBM) in a double bl
2) PBM effective with a moderate dose of light (100 J) combined with a hypoglycemic drug (routinely used by the patients)
3) effective PBM (isolated) with high dose of light (240 J)
4) effective PBM with high dose of light (240 J) combined with hypoglycemic drug (routinely used by the patients)
5) PBM placebo (isolated) with 0 J
and 6) PBM placebo (0 J) combined with hypoglycemic drug (routinely used by the patients). The PBM was applied, bilaterally, on the quadriceps femoris, hamstrings, triceps surae, and ventral region of
2) 1 hour postprandial (pre-intervention by PBM
3) 30 minutes after PBM
4) 3 hours after PBM
5) 6 hours after PBM, 6) 12 hours after PBM and 7) 24 hours after PBM. Between each PBM session, a 1-week washout was applied. All volunteers were undergone to assessments of blood glucose and heart r
E02.774

Sponsors

Universidade do Sagrado Coração
Lead Sponsor
Universidade do Sagrado Coração
Collaborator

Eligibility

Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Volunteers of both genders were recruited; aged between 40 and 80 years; body mass index (BMI) between 20 and 39.9 km/m2, ie, eutrophic; pre-obese or moderately obese subjects (grade I); and obese (grade II). Volunteers should be clinically diagnosed as diabetic (fasting glycemia less than or equal to 126 mg / dL); and be sedentary or irregularly active according to the short version of the IPAQ.

Exclusion criteria

Exclusion criteria: Volunteers who presented cancer were excluded; or history of cancer in the region of the lower and upper limbs; infection; neurological deficits; have coagulation disorders; as well as insulin-dependent volunteers.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: reduced blood glucose of at least 10 mg/dl (measured by monitoring capillary blood glucose) after treatment with phototherapy dose of 100 Joules or 240 Joules;Outcome found 1: reduced blood glucose of at least 10 mg/dl (measured by capillary blood glucose monitoring) after treatment with phototherapy (isolated) using dose of 100 Joules compared to placebo group (0 Joules).

Secondary

MeasureTime frame
Expected outcome 2: changes in heart rate variability (at least 3 units) after treatment with phototherapy doses of 100 Joules or 240 Joules combined or not with hypoglycemic drug (routinely used by the patients) ;Outcome found 2: increase of at least 5 units (un) in the low-frequency component of heart rate variability for placebo treatment (0 J) combined with hypoglycemic drug (routinely used by the patients), and increase of at least 10 units in the low-frequency component for treatment with phototherapy (isolated) with dose of 100 J.

Countries

Brazil

Contacts

Public ContactCleber Ferraresi

Universidade do Sagrado Coração

cleber.ferraresi@gmail.com+55 (14) 2107-7199

Outcome results

None listed

Source: REBEC (via WHO ICTRP)