NCT07047248尚未招募不适用
Short- and Long-Term Effects of Whole-Body Photobiomodulation in Type II Diabetes Patients: A Protocol for a Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Triple (ParticipantCare ProviderOutcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
时间窗: Follow-ups at 3 months and 6 months post-intervention
• Glucose Metabolism: Evaluated through changes in fasting blood glucose levels and HbA1c.
次要结局
- Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).(Follow-ups at 3 months and 6 months post-intervention)
- Sleep Quality: Assessed through the Pittsburgh Sleep Quality Index (PSQI).(Follow-ups at 3 months and 6 months post-intervention)
研究者
Daniel Aguilar Nunez
danunez
University of Malaga
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of Photobiomodulation in a Population Suffering From FibromyalgiaChronic PainFibromyalgiaNCT04248972University of Malaga44
招募中
不适用
Whole-Body Photobiomodulation and Chronic Pain TrialChronic PainNCT05069363Sandwell & West Birmingham Hospitals NHS Trust20
尚未招募
Unknown
Effect of Laser on maternal complications during the Postpartum periodEpisiotomy, Laceration of perineum during childbirth, unspecified,C12.050.351.625G08.686.702RBR-3t8pw38niversidade Federal de Alfenas- Campus Santa Clara
已完成
不适用
General, systemic and cerebral ffects of PhotobiomodulatioVocal cord ParalysisE02.831.727RBR-34h937kniversidade Anhembi Morumbi
招募中
不适用
The effect of Laser on the clinical treatment of secondary Lymphedema of legsDiseases of the circulatory systemLymphoedema not elsewhere classifiedI89.0RBR-4yyktrniversidade Federal de São Paulo