Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 853
- 主要终点
- Body fat percentage and carbohydrate intolerance
研究概览
简要总结
This is a large and comprehensively phenotyped cohort with fasting glycaemia where the predictive value of body composition and anthropometric measures of total and central fat distribution for postprandial carbohydrate intolerance are studied.
详细描述
Subjects aged 18-70 years, who attended the Department of Endocrinology and Nutrition of the Clínica Universidad de Navarra from 2009-2014 for a check-up were offered to participate in the DICAMANO study. 853 subjects agreed to take part. Only those individuals with a normal fasting glucose level (≤5.5 mmol l-1) were analysed. Subjects with T2DM or severe renal, liver or thyroid dysfunction were excluded. Participants were instructed to temporarily discontinue for 48 hours any medication known to affect glucose or lipid metabolism. On the day of the study visit, each subject had a complete routine clinical assessment to evaluate the presence of cardiovascular, respiratory, renal or endocrine disorders. All patients underwent a 75-g OGTT with a concomitant anthropometric study, blood pressure monitoring and lipid profile analyses. They were classified by glucose tolerance on the basis of blood glucose levels according to ADA diagnostic criteria for T2DM (2017). Carbohydrate intolerance was defined as a 2-hOGTT glucose level ≥7.8 mmol l-1 (mg dl-1). Body composition, visceral adipose tissue, anthropometry study, OGTT-based parameters and cardiovascular risk factors are measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting glucose level ≤ 5.5 mmol l-1
排除标准
- •Type 2 diabetes mellitus
- •Severe renal, liver or thyroid dysfunction
结局指标
主要结局
Body fat percentage and carbohydrate intolerance
时间窗: Baseline
Investigate whether body fat percentage estimated by air-displacement plethysmography (Bod-Pod®, Life Measurements, Concord, CA, USA) predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process. Body fat percentage (BF%) is calculated from body density by means of the Siri equation.
Neck circumference as screening tool
时间窗: Baseline
Examine the predictive value of neck circumference as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT)
次要结局
- Waist-to-height ratio as screening tool(Baseline)
- Waist-to-hip ratio as screening tool(Baseline)
- BMI as screening tool(Baseline)
- Body adiposity index as screening tool(Baseline)
- Central fat depot and carbohydrate intolerance(Baseline)
- Central fat depot and cardiometabolic risk(Baseline)
- OGTT-based indices as screening tool of NAFLD(Baseline)
- Body fat percentage and cardiometabolic risk(Baseline)
- OGTT-derived glucose curve as screening tool of NAFLD(Baseline)
- Prevalence of postprandial carbohydrate intolerance(Baseline)
- Oral glucose tolerance test parameters and cardiometabolic profile(Baseline)
- Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation(Baseline)