High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 34
- 主要终点
- Response rate in %
研究概览
简要总结
This pilot randomized controlled trial will involve 34 physically inactive adults aged 35-65 years with overweight or obesity and isolated impaired fasting glucose (i-IFG). The study aims to assess the feasibility of recruiting and retaining participants, implementing study procedures, and evaluating the acceptability of a high-intensity interval training (HIIT) intervention. Additionally, it will investigate the preliminary efficacy of HIIT in reducing fasting plasma glucose levels and addressing the pathophysiology of i-IFG.
详细描述
This 1:1 proof-of-concept randomized controlled trial (RCT) will involve 34 physically inactive adults aged 35-65 years who are overweight or obese and have isolated impaired fasting glycemia (i-IFG). Potentially eligible individuals identified through Emory's MyChart electronic health care records system will undergo initial screening via phone calls. Individuals meeting the eligibility criteria will be invited to the Georgia Clinical and Translational Science Alliance at Emory University Hospital in Atlanta for further assessment. During their visit, participants will complete questionnaires, undergo an oral glucose tolerance test, and provide blood samples for insulin. Individuals identified with i-IFG will be randomized into the intervention or control groups.
Individuals assigned to the intervention group will participate in supervised high-intensity interval training (HIIT) sessions using stationary Spin cycle ergometers, in groups of five or fewer. They will wear continuous glucose monitoring (CGM) devices for 10 days before the intervention, throughout the 8-week intervention period, and for 10 days post-intervention. The intervention will be conducted three times a week for eight weeks at the Aerobic Exercise Laboratory in the Rehabilitation Hospital at Emory University. Control participants will be instructed to refrain from engaging in intense physical activities during the study period and will also wear CGM devices for the same duration. All participants will receive instructions to maintain a eucaloric diet throughout the study.
At baseline and after eight weeks, all participants will undergo physical measurements (anthropometrics, blood pressure, and body composition) as well as biochemical measurements (glucose and insulin levels). Additionally, participants in the intervention group will be invited to participate in qualitative in-depth interviews both before and after the HIIT intervention and will complete an intervention acceptability questionnaire upon completion.
The primary outcomes include feasibility metrics, measures of intervention feasibility, acceptability, and appropriateness, and participants' experiences, perceptions, and satisfaction with the HIIT intervention, as well as facilitators and barriers to participation. Secondary outcomes include: 1) Between-group differences in changes from baseline to 8 weeks in mean fasting plasma glucose and insulin levels, indices of β-cell function and insulin resistance, and physical measurements; and 2) CGM metrics: a) Between-group differences in the proportion of time and mean time spent in nocturnal (00:00-06:00) [58] normoglycemia (60 to <100 mg/dl) during the 8-week intervention period and the 10 days following the intervention; b) Within-participant differences in the proportion of time and mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) between exercise and non-exercise days during the 8-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Staff conducting the outcome assessments will be blinded to the participants' treatment status.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 35-65 years
- •Any race or ethnicity
- •BMI ≥25 kg/m2 (≥23 kg/m2 if Asian decent)
- •Physically inactive (<150 min of moderate-intensity or <75 min of vigorous-intensity aerobic physical activity/week)
- •Will be residing in the same location until completion of the study
- •Isolated impaired fasting glucose on the OGTT: FPG 100-125 mg/dl and 2-hr plasma glucose <140 mg/dl
排除标准
- •History of diabetes
- •Regular exercise training in the past 6 months
- •Enrolled in weight loss programs in the past 6 months
- •Following a specific diet (e.g., ketogenic, Mediterranean)
- •Pregnant women
- •Breastfeeding
- •Taking medications known to affect glucose tolerance (e.g., steroids)
- •Taking beta-blockers and calcium channel blockers
- •Taking weight loss medications
- •Underwent bariatric surgery
- •History of chronic illnesses (e.g., stroke)
- •Individuals satisfying the eligibility criteria will undergo an OGTT (0, 30, 120 min), and those diagnosed with i-IFG (FPG 100 or 110-125 mg/dl and 2-hr PG <140 mg/dl) will be recruited to the study.
研究组 & 干预措施
Intervention Group
Intervention participants will complete 24 supervised high-intensity interval training (HIIT) sessions over 8 weeks, with 3 sessions per week on alternate days. Each HIIT session will consist of a 5-minute warm-up, followed by an interval-based workout phase that includes steady up-tempo cadences, sprints, and climbs, interspersed with recovery periods. The session will conclude with a 5-minute cooldown. The workout sessions will initially last 20 minutes and will progressively increase in time based on participants' tolerance and instructor recommendations. Intensity will start at 75% of the estimated maximal heart rate reserve and will increase by 5% weekly, as tolerated and/or deemed necessary by the instructor, over the 8-week intervention period. Participants will receive instructions to maintain a eucaloric diet throughout the study.
干预措施: High-intensity interval training and eucaloric diet (Behavioral)
Intervention Group
Intervention participants will complete 24 supervised high-intensity interval training (HIIT) sessions over 8 weeks, with 3 sessions per week on alternate days. Each HIIT session will consist of a 5-minute warm-up, followed by an interval-based workout phase that includes steady up-tempo cadences, sprints, and climbs, interspersed with recovery periods. The session will conclude with a 5-minute cooldown. The workout sessions will initially last 20 minutes and will progressively increase in time based on participants' tolerance and instructor recommendations. Intensity will start at 75% of the estimated maximal heart rate reserve and will increase by 5% weekly, as tolerated and/or deemed necessary by the instructor, over the 8-week intervention period. Participants will receive instructions to maintain a eucaloric diet throughout the study.
干预措施: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) (Device)
Control Group
Control participants will be instructed to refrain from engaging in intense physical activities during the study period. They will also receive instructions to maintain a eucaloric diet throughout the study.
干预措施: No intense physical activity and eucaloric diet (Behavioral)
Control Group
Control participants will be instructed to refrain from engaging in intense physical activities during the study period. They will also receive instructions to maintain a eucaloric diet throughout the study.
干预措施: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) (Device)
结局指标
主要结局
Response rate in %
时间窗: Baseline
No. of individuals responded to the invitation/No. of individuals invited.
Screening yield in %
时间窗: Baseline
No. of individuals diagnosed with i-IFG/No. of individuals screened.
Enrolment rate in %
时间窗: Baseline
No. of individuals enrolled/No. of individuals diagnosed with i-IFG.
Time to enrollment (mins)
时间窗: Baseline
Average time taken from sending the invitation to enrolling one participant in the trial.
Intervention compliance in %
时间窗: 8 weeks
No. of HIIT sessions attended/Total no. of HIIT sessions.
Program costs (USD)
时间窗: From baseline to 8 weeks
Includes screening cost, cost of procedures, intervention cost, participant incentives, and other costs.
Staff time (mins)
时间窗: From baseline to 8 weeks
Time spent screening and recruiting participants, time spent delivering the intervention, time spent making phone calls to participants, time spent implementing the study procedures, and time spent on baseline and follow-up assessments.
Retention rate in %
时间窗: 8 weeks
No. of participants attended follow-up visits/No. of participants enrolled.
Feasibility of Intervention Measure (FIM) score
时间窗: 8 weeks
The FIM scale will evaluate the feasibility of the intervention, encompassing questions regarding its implementability, possibility, doability, and ease of use. Responses to the questions in the questionnaire will be recorded on a Likert scale of 1 to 5. The mean total score will be calculated by combining the individual Likert points. Higher scores on the FIM scale indicate greater intervention feasibility.
Theoretical Framework of Acceptability (TFA) score
时间窗: 8 weeks
The acceptability of the intervention will be assessed through the Theoretical Framework of Acceptability (TFA) questionnaire, which explores affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability.
Intervention Appropriate Measure (IAM) score
时间窗: 8 weeks
The Intervention Appropriate Measure (IAM) will evaluate the appropriateness of the intervention, including questions about its fittingness, suitability, applicability, and alignment with participants' needs.
次要结局
- Hepatic Insulin Resistance Index (HIRI)(8 weeks)
- Muscle Insulin Sensitivity Index (MISI)(8 weeks)
- Fat percent (%)(8 weeks)
- Fat mass (kg)(8 weeks)
- Muscle mass (kg)(8 weeks)
- Visceral adipose tissue mass (kg)(8 weeks)
- Waist circumference in cm(8 weeks)
- Waist-to-hip ratio(8 weeks)
- Systolic blood pressure in mmHg(8 weeks)
- Diastolic blood pressure in mmHg(8 weeks)
- Insulinogenic index (IGI)(8 weeks)
- Oral Disposition Index (DIO)(8 weeks)
- Homeostatic Model Assessment of ß-cell function (HOMA-B)(8 weeks)
- Matsuda index(8 weeks)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(8 weeks)
- CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)(From baseline to 8 weeks)
- CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)(From baseline to 8 weeks)
- Fasting plasma glucose (mg/dl)(8 weeks)
- Fasting insulin (µU/ml)(8 weeks)
- Weight in kg(8 weeks)
- BMI in kg/m2(8 weeks)
- CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)(10 days following the intervention)
- CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)(10 days following the intervention)
研究者
Sathish Thirunavukkarasu
Assistant Professor
Emory University