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临床试验/NCT04051229
NCT04051229终止不适用

The Effect of an Exercise Training Program on Metabolic Flexibility in Older Adults With Prediabetes

Wake Forest University Health Sciences4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
4
主要终点
Blood collection_nonesterified fatty acids

研究概览

简要总结

The purpose of the study is to determine if a 6-week exercise training program promotes exercise-induced metabolic flexibility, that is, the ability to switch fuel sources for energy, in older prediabetic adults.

详细描述

This is an investigator initiated single group intervention trial. All participants will receive a 6-week exercise training program with testing occurring before and following the training program. Participants will be provided with 3 days of a high fat diet prior to each of the three testing sessions at the Clinical Research Unit. All who agree to participate will undergo the same intervention.

The goal of this proposal is to study the impact of a 6-week moderate intensity walking training program on exercise induced lipid metabolic flexibility in older adults with prediabetes. Study Investigators will seek to determine if exercise induced lipid oxidation following a high fat diet is increased in trained individuals relative to their baseline.

研究设计

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

入排标准

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

入选标准

  • ≥60 years of age
  • Sedentary prior to the start of the training program (self-reported: less than 30 minutes of exercise for no more than 1 day a week)
  • Prediabetes (measured at first screening: HbA1c = 5.7-6.5%)
  • Must be able to pick-up and consume study provided foods
  • Willingness to provide informed consent and participate in the intervention
  • Must obtain transportation to visits and intervention training sessions
  • No contraindications for involvement in a moderate exercise training program or exercise testing procedures by self-report

排除标准

  • Self-reported diagnosis of a metabolic or chronic disease such as cardiovascular disease, diabetes, Chronic Obstructive Pulmonary Disease, or movement disorders such as Parkinson's disease, Ataxia, Huntington's Disease
  • Current or recent (<12 months) treatment for cancer
  • Body Mass Index <18.5 or >/30.0 kg/m2
  • Tobacco users
  • Febrile or chronic infection within study period
  • Aversion to testing procedures
  • Hypertension, hyperthyroidism, hypothyroidism
  • Unwilling to abstain from ingesting caffeine during study testing periods
  • Unwilling to withhold medications that affect metabolic rate during testing periods
  • Physically active (>30 minutes per day on more than 1 day per week)
  • ECGs that indicate cardiac injury or contraindications to treadmill testing
  • Allergic or intolerant to any study-provided foods

结局指标

主要结局

Blood collection_nonesterified fatty acids

时间窗: Baseline

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_nonesterified fatty acids follow up 1

时间窗: 6 weeks exercise training program

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Metabolic Rate_6 weeks after exercise training program

时间窗: 6 weeks exercise training program

Metabolic rate will be measured by gas exchange using indirect calorimeter. For the first (baseline test) and second (follow up test 1) time we monitor gas exchange, participants will exercise for 20 minutes at a workload that elicits 50% of maximal oxygen consumption as determined by Graded Exercise Test #1 done before the exercise training program. The third time (follow up test 2), participants will exercise for 20 minutes at a workload that elicits 50% of oxygen consumption as determined by Graded Exercise Test #2 done after the exercise training program.

Blood collection_lactate Baseline

时间窗: Baseline

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_lactate follow up 2

时间窗: 3-10 days following Follow-Up Test 1

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_glucose baseline

时间窗: Baseline

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_glucose follow up 1

时间窗: 6 weeks exercise training program

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_insulin

时间窗: Baseline

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Metabolic Rate-Baseline

时间窗: Baseline

Metabolic rate will be measured by gas exchange using indirect calorimeter. For the first (baseline test) and second (follow up test 1) time we monitor gas exchange, participants will exercise for 20 minutes at a workload that elicits 50% of maximal oxygen consumption as determined by Graded Exercise Test #1 done before the exercise training program. The third time (follow up test 2), participants will exercise for 20 minutes at a workload that elicits 50% of oxygen consumption as determined by Graded Exercise Test #2 done after the exercise training program.

Blood collection_lactate follow up 1

时间窗: 6 weeks exercise training program

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_glucose follow up 2

时间窗: 3-10 days following Follow-Up Test 1

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_nonesterified fatty acids follow up 2

时间窗: 3-10 days following Follow-Up Test 1

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_insulin follow up 1

时间窗: 6 weeks exercise training program

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

Blood collection_insulin follow up 2

时间窗: 3-10 days following Follow-Up Test 1

At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

次要结局

  • VO2 peak(6 weeks (Post exercise training))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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