The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals With Prediabetes or Type 2 Diabetes Mellitus: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Prevalence of hypoglycemia
研究概览
简要总结
The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are:
- Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve?
- How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort?
Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures:
- One control day, when they will not exercise;
- A high-effort resistance exercise session;
- A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years;
- •presence of prediabetes (fasting glycemia between 100 and 125 mg/dL or glycated hemoglobin [A1c] between 5.7 and 6.4%) or T2DM (fasting glycemia 126 mg/dL or above or A1c 6.5% or above).
排除标准
- •renal failure,
- •liver disease,
- •uncontrolled hypertension (equal or greater than 160 mmHg systolic and/or equal or greater than 100 mmHg diastolic),
- •history of severe cardiovascular problems,
- •in case of oral hypoglycemic drugs usage, being on them for less than 6 months,
- •inability to perform resistance exercise,
- •being pregnant or trying to become pregnant during the course of the study,
- •use of oral contraceptives,
- •prisoners,
- •persons requiring a legally authorized representative,
- •non-English speakers.
研究组 & 干预措施
Control session
The control session all procedures will be identical to the high-effort session.
干预措施: Control (Behavioral)
high-effort session
Participants will perform sets with as many repetitions they can each set.
干预措施: High-effort session (Behavioral)
low-effort session
Participants will perform sets with half of the anticipated number of repetitions of the high-effort session.
干预措施: Low-effort session (Behavioral)
结局指标
主要结局
Prevalence of hypoglycemia
时间窗: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentrations \<70 mg/dL (measured in minutes)
Time in range
时间窗: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
Glucose concentration
时间窗: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Prevalence of hyperglycemia
时间窗: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentrations \>180 mg/dL (measured in minutes)
Glucose concentration
时间窗: For 48 hours during each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Glucose concentration
时间窗: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Glucose concentration
时间窗: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Glucose concentration
时间窗: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Time in range
时间窗: For 48 hours during each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
Time in range
时间窗: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
Time in range
时间窗: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
Time in range
时间窗: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
Prevalence of hyperglycemia
时间窗: For 48 hours during each situation (arm) of the study
Time of glucose concentrations \>180 mg/dL (measured in minutes)
Prevalence of hyperglycemia
时间窗: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentrations \>180 mg/dL (measured in minutes)
Prevalence of hyperglycemia
时间窗: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentrations \>180 mg/dL (measured in minutes)
Prevalence of hyperglycemia
时间窗: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentrations \>180 mg/dL (measured in minutes)
Prevalence of hypoglycemia
时间窗: For 48 hours during each situation (arm) of the study
Time of glucose concentrations \<70 mg/dL (measured in minutes)
Prevalence of hypoglycemia
时间窗: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentrations \<70 mg/dL (measured in minutes)
Prevalence of hypoglycemia
时间窗: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentrations \<70 mg/dL (measured in minutes)
Prevalence of hypoglycemia
时间窗: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentrations \<70 mg/dL (measured in minutes)
次要结局
- Rating of Discomfort scale(Before and 5 minutes after the resistance exercise sessions.)
- Resistance Training Intensity by the Omni Perceived Exertion Scale(After each set of each exercise performed.)
- Feeling scale(Before and immediately after the resistance exercise sessions.)
- Physical Activity Enjoyment Scale(Immediately after the resistance exercise sessions.)
- Self-efficacy scale(Immediately after the resistance exercise sessions.)
- Session rating of perceived exertion(5 minutes after the resistance exercise sessions.)
研究者
Flavio de Castro Magalhaes
Assistant Professor
University of New Mexico