HIIT in Isolated IFG: A Proof-of-Concept Study

NCT06143345 | Withdrawn DMC

• 2 other identifiers: STUDY00005855UL1TR002378
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Isolated Impaired Fasting Glucose

Keywords

Prediabetes; Obesity; High-intensity interval training; Isolated impaired fasting glucose

Outcome Measures

Primary Outcomes (11)

• 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 %

  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

Secondary Outcomes (23)

• Fasting plasma glucose (mg/dl)

  8 weeks

• Fasting insulin (µU/ml)

  8 weeks

• Weight in kg

  8 weeks

• BMI in kg/m2

  8 weeks

• Waist circumference in cm

  8 weeks

Study Arms (2)

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.

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.

Behavioral: No intense physical activity and eucaloric diet; Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)

Interventions

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.

Control Group

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\' 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.

Also known as: HIIT intervention

Intervention Group

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.

Also known as: Dexcom G6 Pro CGM sensor

Control Group; Intervention Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Emory University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Related Publications (1)

• 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.

  PMID: 39977858 DERIVED

MeSH Terms

Conditions

Prediabetic State; Obesity

Interventions

High-Intensity Interval Training; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Sathish Thirunavukkarasu, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff conducting the outcome assessments will be blinded to the participants' treatment status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share