A non-invasive approach for Type 2 Diabetes and Hypertension risk evaluation in at-risk patients.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary outcome of the trial will be a model based evaluation system to identify at risk type 2 diabetes patients
研究概览
简要总结
Background:
Currently, Type 2 diabetes can bediagnosed by testing a person’s blood for glucose levels. There are severalblood glucose tests that may be used, including fasting plasma glucose (FPG),random capillary glucose (RCG) and oral glucose tolerance (OGTT) tests. TheOGTT has been considered the standard test. The OGTT test involves someonefasting overnight before blood is taken the next morning from a vein in theirarm. HbA1c tests reflect the average level of glucose in the blood over aperiod of a few months and do not require fasting. They can be conducted oneither blood taken from a vein in the arm or, in some cases, a drop of bloodfrom a finger-prick. Because blood glucose or HbA1c tests involve drawing bloodand/or fasting, they may be considered inconvenient for mass screening for type2 diabetes. Thermography, which combines a high degree of accuracy withcomplete safety, meets the need. Thermography involves the detection of heatenergy by an infrared-sensitive device, with subsequent conversion to electricalenergy, amplification, and a suitable means of display. Our invention is basedon the principle of using the temperature distribution observed in the body tomeasure the parameters indicating the structural and functional characteristicsof the vascular metabolism.
Justification: The functioning of the vital organs isassociated with metabolic heat, which is transferred to the skin surface by thecirculating blood. As the heat emitted from the skin, which has an emissivityof 0.98 is related to blood flow. Measurement of the heat emission gives anindicative measure of blood flow. Any dysfunction, namely atherosclerosis thatoccurs in blood vessels causes the heat distribution observed to differ fromthe heat distribution of the skin observed under healthy conditions. Vasculardysfunction in a person creates vascular complications, such as endothelialdysfunction and atherosclerosis over time. These vascular impairments arebecoming prominent in subjects who are developing these chronic conditions orexisting patients. Our invention uses biomarkers associated with vascularstructure and functions measured from thermal imaging for assessing vascularhealth. This vascular health provides an early indication of the development ofdiabetes and hypertension.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than 30 years with one or more of the following risk factors: BMI > 25 kg/m² Elevated waist circumference, > 35 inches for women and > 40 inches for men Habitually physically inactive (does not exercise regularly) Has delivered a baby weighing > 4kg or diagnosed with gestational diabetes Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication Has insulin resistance which can be identified using HOMMA-IR modelling Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS) Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last three years.
排除标准
- •Under 25 years of age Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Current chemotherapy, or chemotherapy within the past 12 months Receiving medications that fluoresce Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity).
结局指标
主要结局
The primary outcome of the trial will be a model based evaluation system to identify at risk type 2 diabetes patients
时间窗: 8 weeks
次要结局
- The secondary outcome will be identifying patients who are at risk for vascular complications like hypertension(8 weeks)