Study of association of salivary adipokines with prediabetes and Type 2 diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The difference in adipokines level in saliva between normal, prediabetic and Newly diagnosed diabetic patients at the end of 2yrs
研究概览
简要总结
India has more than 65 million adults with Type 2 Diabetes Mellitus (T2DM) and also has a large number with subclinical stages of glycaemia including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). At present people with high risk of diabetes are identified by blood test such as Oral glucose tolerance Test and/or glycosylated haemoglobin A1c (HbA1c). Dysregulated actions of adipokines have major roles in development of metabolic diseases such as diabetes. Adipokines influence systemic insulin resistance and also regulate inflammatory process and/or are likely to have major pathological role in the development of diabetes. It is also likely that these abnormalities occur even in sub clinical stages of T2DM which when identified would provide an early opportunity to institute early intervention using life style changes which are proven to be effective in all ethnic groups.The measurements of adipokines such as adiponectin, apelin, visfatin and vaspin which have inter related regulatory roles, in saliva if found to be sensitive would provide a non-invasive, simple method of assessing persons with high risk of T2DM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Arm 1 Fasting plasma glucose test (FPG).
- •less than 110mg/dl and Oral glucose tolerance test (OGTT).
- •less than 140 mg/dl 2.Arm 2 Fasting plasma glucose test (FPG) – more than or equal to 110mg/dl to less than 126 mg/dl, Oral glucose tolerance test (OGTT).
- •more than or equal to 140mg/dl to less than or equal 199 mg/dl 3.Arm 3 Fasting plasma glucose (FPG) more than or equal to 126 mg/dL, and/or 2-hPG(2-hour post load plasma glucose) more than or equal to 200 mg/dL 4.Person given written informed consent to participate in this study in accordance with local regulations 5.Person must be available for and willing to attend all evaluation visits.
排除标准
- •1.Smokers for over a period of 6 months (1 or more cigarettes per day) 2.Betel nut chewer over a period of 3 months 3.Person with bleeding disorders 4.Person who require antibiotic prophylaxis prior to dental treatment 5.History of antibiotic therapy within 3 months prior to the study 6.Person with uncontrolled systemic disease 7.Person not willing to participate in the study 8.Individuals who are cognitively impaired and/or who are unable to give informed consent.
结局指标
主要结局
The difference in adipokines level in saliva between normal, prediabetic and Newly diagnosed diabetic patients at the end of 2yrs
时间窗: Baseline and 24 months
次要结局
- Changes in the following parameters at 2 yrs between normal, prediabetic and Newly diagnosed diabetic patients(1.Weight , BMI and Blood Pressure)