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临床试验/NCT04320433
NCT04320433Unknown不适用

Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation

研究概览

简要总结

The main aim of this study is to determine the inter-day reliability, by using indirect calorimetry, of the post-prandial macronutrient oxidation and energy expenditure after consuming oral glucose load solution.

详细描述

The maintenance of blood glucose concentrations and the oxidation of carbohydrate after consuming carbohydrate is related with a low risk of mortality and morbidity from cardiometabolic diseases. The oral glucose tolerance test is a diagnostic test widely used in the clinical field. However, its inter-day reliability has not been deeply studied. Therefore, it is of clinical interest to study the inter-day reliability of the diagnostic test oral glucose tolerance test using indirect calorimetry and monitoring the response of the glucose levels.

20 young adults will undergo two trials visit with 7 days of separation between conditions. Each evaluation day will conform to the following tests:

  1. Basal metabolic rate assessment through indirect calorimetry.
  2. Basal heart rate variability through heart rate monitor.
  3. Intake of the corresponding glucose load solution.
  4. Postprandial nutrient oxidation and energy expenditure assessment through indirect calorimetry
  5. Glucose monitoring through Glucose meter.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female
  • Ages 18-30 years
  • BMI: 18-27.5 kg/m2
  • Stable weight over the last 3 months (body weight changes<35kg)
  • Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

排除标准

  • History of cardiovascular disease
  • Diabetes or hypertension
  • Pregnant, planning to become pregnant, or breastfeeding
  • Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
  • Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
  • Claustrophobia
  • Needle phobia
  • Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

结局指标

主要结局

Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation

时间窗: 7 days

Reliability

次要结局

  • Inter-day reliability, 7 days apart, in post-prandial energy expenditure(7 days)
  • Inter-day reliability, 7 days apart, in glucose levels(7 days)

研究者

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

Jonatan Ruiz Ruiz

Associate professor

Universidad de Granada

研究点 (2)

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