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临床试验/NCT01796184
NCT01796184已完成不适用

Inflammation and Glycation in a General Adult Population

Hospital Clinico Universitario de Santiago1 个研究点 分布在 1 个国家目标入组 1,516 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,516
试验地点
1
主要终点
Glycation gap levels

研究概览

简要总结

Background. Obesity, insulin resistance and type 2 diabetes are closely associated with chronic inflammation characterized by abnormal cytokine production. Some authors have found discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control, suggesting that a "glycation gap", defined as the difference between the HbA1c concentration and that predicted by the fructosamine concentration, could explain the excess interindividual variation in HbA1c.

The present study was aimed to examine the association between inflammation, sociodemographic (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco consumption), and common diseases. In addition, we also examine levels of blood glucose, HbA1c, fructosamine and "glycation gap" determining the prevalence of "high glycators" in a general adult population and their association with lifestyles and prevalent diseases.

Methods. Selection of a random sample of the general adult population from a single municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling includes 3,500 subjects. Considering approximate 67% participation rate, the final study population would include more than 2,000 individuals. The standard workup includes structured questionnaires, skin prick test, periodontal examination, psychological tests, physical examination and blood determinations to allow for categorization of participants in terms of basic demographics, profession, education level, socioeconomic level, quality of life, physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes, metabolic syndrome, hypertension, cardiovascular disease, and liver disease. We determine blood levels of inflammation markers, HBA1c, fructosamine and glucose. We will collect a urine sample for microalbuminuria determination. In addition, blood will be drawn to be stored at the Biobank of our Hospital. One half of participants (~1000 individuals) will undergo continuous glucose monitoring. The design is cross-sectional, followed by a longitudinal study using population registries for the determination of events (mortality).

Discussion. This comprehensive study in a general adult population provides an excellent opportunity to determine serum concentrations of inflammation and glycation markers and how they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic diseases. The findings from this study should also help to find out the relationship between glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation markers.

Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male
  • 18 years and older
  • No evidence of acute illness, fever, undue stress

排除标准

  • Unable to give informed consent
  • Terminal cancer
  • Allergy to adhesives
  • Any concomitant medical condition that would likely affect the evaluation of device performance

结局指标

主要结局

Glycation gap levels

时间窗: At time of interview and after one week

The glycation gap is calculated as the difference between measured HbA1c and predicted HbA1c from the fructosamine and glucose levels.

次要结局

  • Interstitial glucose levels(6 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Gude

PhD, MD

Hospital Clinico Universitario de Santiago

研究点 (1)

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