Dysfunctional Adiposity and Glucose Impairment (DICAMANO)
2018年4月24日 更新者：Clinica Universidad de Navarra, Universidad de Navarra
Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
853
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
概率样本
研究人群
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
描述
Inclusion Criteria:
- Fasting glucose level ≤ 5.5 mmol l-1
- BMI ≥ 25
Exclusion Criteria:
- Type 2 diabetes mellitus
- Severe renal, liver or thyroid dysfunction
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body fat percentage and carbohydrate intolerance
大体时间：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. |
Baseline
|
|
Neck circumference as screening tool
大体时间：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)
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Waist-to-hip ratio as screening tool
大体时间：Baseline
|
Examine the predictive value of waist-to-hip ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
Waist-to-hip ratio was calculated as waist circumference divided by hip circumference.
Waist circumference was measured at the midpoint between the iliac crest and the rib cage on the mid-axillary line, and hip circumference at the level of the greater trochanters was measured to the nearest millimetre using a flexible tape.
|
Baseline
|
|
Waist-to-height ratio as screening tool
大体时间：Baseline
|
Examine the predictive value of waist-to-height ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
Waist-to-height ratio was calculated as waist circumference divided by height.
|
Baseline
|
|
BMI as screening tool
大体时间：Baseline
|
Examine the predictive value of body adiposity index (BMI) as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
BMI was calculated as weight in kilograms divided by height in meters squared.
|
Baseline
|
|
Body adiposity index as screening tool
大体时间：Baseline
|
Examine the predictive value of body adiposity index (BAI) ([hip circumference/height1.5]-18)
as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
|
Baseline
|
|
Central fat depot and carbohydrate intolerance
大体时间：Baseline
|
Investigate whether central fat depot predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process.
Visceral and abdominal adiposity was quantified by the use of the abdominal bioelectrical impedance analysis device ViScan (Tanita AB-140, Tanita Corp., Tokyo, Japan).
|
Baseline
|
|
Central fat depot and cardiometabolic risk
大体时间：Baseline
|
Investigate whether a higher central fat depot is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea). Body fat percentage (BF%) is calculated from body density by means of the Siri equation. |
Baseline
|
|
Body fat percentage and cardiometabolic risk
大体时间：Baseline
|
Investigate whether a higher body fat percentage is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea). Body fat percentage (BF%) is calculated from body density by means of the Siri equation. |
Baseline
|
|
Prevalence of postprandial carbohydrate intolerance
大体时间：Baseline
|
Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia
|
Baseline
|
|
Oral glucose tolerance test parameters and cardiometabolic profile
大体时间：Baseline
|
Verification of the utility of the two-hour OGTT glucose value to select those individuals with higher cardiometabolic risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea).
|
Baseline
|
|
Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation
大体时间：Baseline
|
Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.
|
Baseline
|
|
OGTT-based indices as screening tool of NAFLD
大体时间：Baseline
|
Examine whether OGTT-based ß-cell function and insulin resistance indices could be used as screening tools for the selection of patients who are most likely to benefit from a NAFLD-study.
|
Baseline
|
|
OGTT-derived glucose curve as screening tool of NAFLD
大体时间：Baseline
|
Examine whether the glucose response curve could be used as screening tool for the selection of patients who are most likely to benefit from a NAFLD-study.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Gema Frühbeck, PhD、Clinica Universidad de Navarra
- 首席研究员：Belén Pérez Pevida, MD、Clinica Universidad de Navarra
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年1月29日
初级完成 (实际的)
2014年8月28日
研究完成 (实际的)
2016年1月28日
研究注册日期
首次提交
2018年2月6日
首先提交符合 QC 标准的
2018年4月23日
首次发布 (实际的)
2018年4月24日
研究记录更新
最后更新发布 (实际的)
2018年4月25日
上次提交的符合 QC 标准的更新
2018年4月24日
最后验证
2018年2月1日
更多信息
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