Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers
Condition: Insulin Resistance; Inflammatory Markers
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      It is an interventional study in which 60 women estimated to enroll according to random
      allocation and assigned into two groups equal. The study group will receive active low level
      laser in addition to diet recommendations while the control group will stick to the same line
      of treatment but with sham laser application. The laser consists of semiconductor and
      operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10
      individual laser beams for the wrist and an additional adapter for nasal stimulation. The
      output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient
      temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used
      for a variable irradiation period of 10-60 min. the device will be applied on specific
      acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery
      acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3
      times per week for three months
    

Detailed description: 
      PURPOSE:

      To determine the effectiveness of low level laser therapy on insulin resistance and
      inflammatory biomarkers in obese postmenopausal breast cancer risk women

      BACKGROUND:

      The American Obesity Association (2002, 2003) defines obesity as 'a complex, multifactorial
      chronic disease involving environmental (social and cultural), genetic, physiologic,
      metabolic, behavioral, and psychological components'. However, the most commonly used
      definitions of obesity are based on BMI, which is defined as weight in kilograms divided by
      height in meters squared. In adults, obesity is generally defined as a BMI of 30.0 or
      greater. Obesity has become a major contributor to the global burden of chronic disease and
      disability. It is a complex condition with serious social and psychological dimensions,
      affecting virtually all ages and socioeconomic group Obesity is associated with an increased
      risk of developing insulin resistance and type 2 diabetes. In obese individuals, adipose
      tissue releases increased amounts of non-esterified fatty acids, glycerol, hormones,
      proinflammatory cytokines and other factors that are involved in the development of insulin
      resistance. In overweight and obesity, there exists low-grade chronic inflammation
      characterized by the increase of cytokines and serum concentrations such as fibrinogen and
      C-reactive protein (CRP) The areas of low - intensity laser use have expanded in several
      conditions by different mechanisms and ways. LLLT has been used as an important tool for the
      control of the inflammatory process. Its anti-inflammatory effect has been studied and its
      ability to induce analgesia under different conditions has also been reported. Because laser
      acupuncture appears to be safe, it could be considered as a complementary form of palliative
      care for prevention of cancer risk, especially for clinical problems for which conventional
      care options are limited. Investigations suggest the benefits of low-level laser therapy
      (LLLT) to improve noninvasive body contouring treatments, inflammation, insulin resistance
      and to reduce body fat.

      HYPOTHESES:

      Low level laser therapy in form of laser watch has no effect on insulin resistance
      inflammatory biomarkers in obese postmenopausal breast cancer risk women

      RESEARCH QUESTION:

      Does low level laser therapy has an effect on insulin resistance inflammatory biomarkers in
      obese postmenopausal breast cancer risk women?
    

Intervention name(s): low level laser in addition to diet recommendations; sham laser application in addition to diet recommendations
Intervention type(s): Device; Other
Intervention description(s): The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt; sham laser application in addition to diet recommendations
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention