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临床试验/NCT05845827
NCT05845827已完成不适用

Impact of Dietary Intake on Continuous Glucose Patterns Considering Cardiorespiratory Fitness Levels.

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Completion of the at-home glucose tolerance test

研究概览

简要总结

Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims:

SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor.

SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response.

SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents and young adults, ages 14-22 years

排除标准

  • Previous diagnosis of type 1 or 2 diabetes
  • Previous diagnosis of hyperlipidemia or other metabolic disease
  • Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
  • Allergies to milk.
  • Inability to participant in the maximal exercise test on the treadmill.
  • Individuals not having android or IOS phones
  • Individuals who cannot speak and/or write in English.

结局指标

主要结局

Completion of the at-home glucose tolerance test

时间窗: 7-10 days

Participants will be asked to drink a 75-gram glucose tolerance test. The researchers will measure the number of participants that self-reported drinking the shake at fasting. The goal will be 90% of participants self-report drinking the shake at fasting.

Number of days wearing the continuous glucose monitor

时间窗: 7-10 days

The researchers will measure the amount of time each participant wears the continuous glucose monitor. The goal is to have participants wear the monitor for \>90% of the time in the study.

Number of dietary records completed by each study participant

时间窗: 7-10 days

The researchers will measure dietary intake using a mobile phone application called BiteSnap. The goal is to have participants report \>90% of their meals using mobile phone photos to extract nutrient information.

次要结局

  • Identify nutrients associated with an elevated glucose response, measured by the continuous glucose monitor.(7-10 days)
  • Access the relationship between fitness levels and glucose response to standard of care meal tests.(7-10 days)

研究者

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

Jennifer L. Meijer

Assistant Professor of Medicine

Dartmouth-Hitchcock Medical Center

研究点 (1)

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