Isolated Impaired Fasting GlucoseNCT06143345
HIIT in Isolated IFG: A Proof-of-Concept Study
A study testing High-intensity interval training and eucaloric diet, No intense physical activity and eucaloric diet and Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) in people with Isolated Impaired Fasting Glucose, run by Emory University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Isolated Impaired Fasting Glucose
- What is being tested?
- High-intensity interval training and eucaloric diet, No intense physical activity and eucaloric diet and Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- Smokers
- Taking medications known to affect glucose tolerance (e.g., steroids)
- Taking beta-blockers and calcium channel blockers
- Taking weight loss medications
- Underwent bariatric surgery
- Anemia
- 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.
About this study
Official title: High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study
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.
Read the detailed description
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.
- Conditions
- Isolated Impaired Fasting Glucose
- Being tested
- High-intensity interval training and eucaloric diet, No intense physical activity and eucaloric diet, Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)
- Keywords
- Prediabetes, Obesity, High-intensity interval training, Isolated impaired fasting glucose
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training and eucaloric dietBehavioural
Also called HIIT intervention
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.
No intense physical activity and eucaloric dietBehavioural
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.
Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)Device
Also called Dexcom G6 Pro CGM sensor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-intensity interval training and eucaloric diet; Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) |
| 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. Receives: Behavioral: No intense physical activity and eucaloric diet; Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate in %
No. of individuals responded to the invitation/No. of individuals invited.
Measured: Baseline
Screening yield in %
No. of individuals diagnosed with i-IFG/No. of individuals screened.
Measured: Baseline
Enrolment rate in %
No. of individuals enrolled/No. of individuals diagnosed with i-IFG.
Measured: Baseline
Time to enrollment (mins)
Average time taken from sending the invitation to enrolling one participant in the trial.
Measured: Baseline
Intervention compliance in %
No. of HIIT sessions attended/Total no. of HIIT sessions.
Measured: 8 weeks
Program costs (USD)
Includes screening cost, cost of procedures, intervention cost, participant incentives, and other costs.
Measured: 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.
Measured: From baseline to 8 weeks
Retention rate in %
No. of participants attended follow-up visits/No. of participants enrolled.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (23)
Fasting plasma glucose (mg/dl)
Change in fasting plasma glucose from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Fasting insulin (µU/ml)
Change in fasting insulin from baseline to 8 weeks will be compared between study groups.
Measured: 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.
Measured: 8 weeks
BMI in kg/m2
Change in BMI from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Waist circumference in cm
Change in waist circumference from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Waist-to-hip ratio
Change in waist-to-hip ratio from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Systolic blood pressure in mmHg
Change in systolic BP from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Diastolic blood pressure in mmHg
Change in diastolic BP from baseline to 8 weeks will be compared between study groups.
Measured: 8 weeks
Insulinogenic index (IGI)
IGI is a measure of early-phase insulin secretion.
Measured: 8 weeks
Oral Disposition Index (DIO)
DIO is a measure of ß-cell function.
Measured: 8 weeks
Homeostatic Model Assessment of ß-cell function (HOMA-B)
HOMA-B is a measure of ß-cell function.
Measured: 8 weeks
Matsuda index
Matsuda index is a measure of insulin resistance.
Measured: 8 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a measure of insulin resistance.
Measured: 8 weeks
Hepatic Insulin Resistance Index (HIRI)
HIRI is a measure of hepatic insulin resistance.
Measured: 8 weeks
Muscle Insulin Sensitivity Index (MISI)
MISI is a measure of muscle insulin resistance.
Measured: 8 weeks
Fat percent (%)
Fat percent will be obtained by bioimpedance analysis.
Measured: 8 weeks
Fat mass (kg)
Fat mass will be obtained by bioimpedance analysis.
Measured: 8 weeks
Muscle mass (kg)
Muscle mass will be obtained by bioimpedance analysis.
Measured: 8 weeks
Visceral adipose tissue mass (kg)
Visceral adipose tissue mass will be obtained by bioimpedance analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Due to operational issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Isolated Impaired Fasting GlucoseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Sathish Thirunavukkarasu, Emory University
- Investigators
- Sathish Thirunavukkarasu, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143345
- Sponsor's protocol ID
- STUDY00005855
- Other IDs
- UL1TR002378
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39977858
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06143345
- Acronym / sponsor ID
- STUDY00005855
- Conditions
- Isolated Impaired Fasting Glucose
- Keywords
- Prediabetes, Obesity, High-intensity interval training, Isolated impaired fasting glucose
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to operational issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: High-intensity interval training and eucaloric diet, Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)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. |
| Control Group | Active comparator | Behavioral: No intense physical activity and eucaloric diet, Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training and eucaloric dietAlso: HIIT interventionIntervention 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. | Behavioural | Intervention Group |
| No intense physical activity and eucaloric dietControl 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. | Behavioural | Control Group |
| Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)Also: Dexcom G6 Pro CGM sensorThe 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. | Device | Control Group, Intervention Group |
Primary outcome
Response rate in %
Time frame: Baseline
No. of individuals responded to the invitation/No. of individuals invited.
Screening yield in %
Time frame: Baseline
No. of individuals diagnosed with i-IFG/No. of individuals screened.
Enrolment rate in %
Time frame: Baseline
No. of individuals enrolled/No. of individuals diagnosed with i-IFG.
Time to enrollment (mins)
Time frame: Baseline
Average time taken from sending the invitation to enrolling one participant in the trial.
Intervention compliance in %
Time frame: 8 weeks
No. of HIIT sessions attended/Total no. of HIIT sessions.
Program costs (USD)
Time frame: From baseline to 8 weeks
Includes screening cost, cost of procedures, intervention cost, participant incentives, and other costs.
Staff time (mins)
Time frame: 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 %
Time frame: 8 weeks
No. of participants attended follow-up visits/No. of participants enrolled.
Feasibility of Intervention Measure (FIM) score
Time frame: 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
Time frame: 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
Time frame: 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.
23 secondary outcomes
Fasting plasma glucose (mg/dl)
Time frame: 8 weeks
Fasting insulin (µU/ml)
Time frame: 8 weeks
Weight in kg
Time frame: 8 weeks
BMI in kg/m2
Time frame: 8 weeks
Waist circumference in cm
Time frame: 8 weeks
Waist-to-hip ratio
Time frame: 8 weeks
Systolic blood pressure in mmHg
Time frame: 8 weeks
Diastolic blood pressure in mmHg
Time frame: 8 weeks
Insulinogenic index (IGI)
Time frame: 8 weeks
Oral Disposition Index (DIO)
Time frame: 8 weeks
Homeostatic Model Assessment of ß-cell function (HOMA-B)
Time frame: 8 weeks
Matsuda index
Time frame: 8 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 8 weeks
Hepatic Insulin Resistance Index (HIRI)
Time frame: 8 weeks
Muscle Insulin Sensitivity Index (MISI)
Time frame: 8 weeks
Fat percent (%)
Time frame: 8 weeks
Fat mass (kg)
Time frame: 8 weeks
Muscle mass (kg)
Time frame: 8 weeks
Visceral adipose tissue mass (kg)
Time frame: 8 weeks
CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)
Time frame: From baseline to 8 weeks
CGM metric: Proportion of time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)
Time frame: 10 days following the intervention
CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)
Time frame: From baseline to 8 weeks
CGM metric: Mean time spent in nocturnal (00:00-06:00) normoglycemia (60 to <100 mg/dl)
Time frame: 10 days following the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 39977858Thirunavukkarasu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sathish Thirunavukkarasu, PhD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and eucaloric diet, No intense physical activity and eucaloric diet and Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor) in people with Isolated Impaired Fasting Glucose, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate in % (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06143345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.