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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002378 | U.S. NIH Grant/Contract | View source |
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Due to operational issues
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity interval training and eucaloric diet | Behavioral | 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&#39; tolerance and instructor recommendations. Intensity will start at 75% of 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate in % | No. of individuals responded to the invitation/No. of individuals invited. | Baseline |
| Screening yield in % | No. of individuals diagnosed with i-IFG/No. of individuals screened. | Baseline |
| Enrolment rate in % | No. of individuals enrolled/No. of individuals diagnosed with i-IFG. | Baseline |
| Time to enrollment (mins) | Average time taken from sending the invitation to enrolling one participant in the trial. | Baseline |
| Intervention compliance in % | No. of HIIT sessions attended/Total no. of HIIT sessions. | 8 weeks |
| Program costs (USD) | Includes screening cost, cost of procedures, intervention cost, participant incentives, and other costs. | From baseline to 8 weeks |
| Staff time (mins) | 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. | From baseline to 8 weeks |
| Retention rate in % |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose (mg/dl) | Change in fasting plasma glucose from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Fasting insulin (µU/ml) | Change in fasting insulin from baseline to 8 weeks will be compared between study groups. |
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Inclusion criteria:
Exclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sathish Thirunavukkarasu, PhD | Emory University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39977858 | Derived | Thirunavukkarasu S, Ziegler TR, Weber MB, Staimez L, Lobelo F, Millard-Stafford ML, Schmidt MD, Venkatachalam A, Bajpai R, El Fil F, Prokou M, Kumar S, Tapp RJ, Shaw JE, Pasquel FJ, Nocera JR. High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: Protocol for a Proof-of-Concept Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 20;14:e59842. doi: 10.2196/59842. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Staff conducting the outcome assessments will be blinded to the participants' treatment status.
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| No intense physical activity and eucaloric diet | Behavioral | 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. |
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| Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) | Device | The continuous glucose monitoring (CGM) system comprises a sensor, a transmitter, and a receiver. The sensor measures interstitial fluid glucose levels every 5 minutes, and the transmitter wirelessly sends this glucose data to the receiver. Both intervention and control participants will wear the CGM device in a blinded mode for 10 days before starting the intervention, throughout the 8-week intervention period, and for 10 days post-intervention. |
|
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No. of participants attended follow-up visits/No. of participants enrolled.
| 8 weeks |
| Feasibility of Intervention Measure (FIM) score | 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. | 8 weeks |
| Theoretical Framework of Acceptability (TFA) score | 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. | 8 weeks |
| Intervention Appropriate Measure (IAM) score | The Intervention Appropriate Measure (IAM) will evaluate the appropriateness of the intervention, including questions about its fittingness, suitability, applicability, and alignment with participants' needs. | 8 weeks |
| 8 weeks |
| Weight in kg | Weight will be measured using a digital weighing scale (Welch Ally-Scale-Tronix, NY, USA) with precision to the nearest 0.1 kg. The change in weight from baseline to 8 weeks will be compared between the intervention and control groups. | 8 weeks |
| BMI in kg/m2 | Change in BMI from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Waist circumference in cm | Change in waist circumference from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Waist-to-hip ratio | Change in waist-to-hip ratio from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Systolic blood pressure in mmHg | Change in systolic BP from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Diastolic blood pressure in mmHg | Change in diastolic BP from baseline to 8 weeks will be compared between study groups. | 8 weeks |
| Insulinogenic index (IGI) | IGI is a measure of early-phase insulin secretion. | 8 weeks |
| Oral Disposition Index (DIO) | DIO is a measure of ß-cell function. | 8 weeks |
| Homeostatic Model Assessment of ß-cell function (HOMA-B) | HOMA-B is a measure of ß-cell function. | 8 weeks |
| Matsuda index | Matsuda index is a measure of insulin resistance. | 8 weeks |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is a measure of insulin resistance. | 8 weeks |
| Hepatic Insulin Resistance Index (HIRI) | HIRI is a measure of hepatic insulin resistance. | 8 weeks |
| Muscle Insulin Sensitivity Index (MISI) | MISI is a measure of muscle insulin resistance. | 8 weeks |
| Fat percent (%) | Fat percent will be obtained by bioimpedance analysis. | 8 weeks |
| Fat mass (kg) | Fat mass will be obtained by bioimpedance analysis. | 8 weeks |
| Muscle mass (kg) | Muscle mass will be obtained by bioimpedance analysis. | 8 weeks |
| Visceral adipose tissue mass (kg) | Visceral adipose tissue mass will be obtained by bioimpedance analysis. | 8 weeks |
| CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) | Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) during the 8-week intervention period. | From baseline to 8 weeks |
| CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) | Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) during the 10 days following the intervention. | 10 days following the intervention |
| CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) | Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) during the 8-week intervention period. | From baseline to 8 weeks |
| CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) | Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl) during the 10 days following the intervention. | 10 days following the intervention |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |