WithdrawnNot Applicable

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

Stopped: Due to operational issues

0Started 2026-06-01

Plain-language 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.

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Response rate in %

Timeframe: Baseline

Screening yield in %

Timeframe: Baseline

Enrolment rate in %

Timeframe: Baseline

Time to enrollment (mins)

Timeframe: Baseline

Intervention compliance in %

Timeframe: 8 weeks

Program costs (USD)

Timeframe: From baseline to 8 weeks

Staff time (mins)

Timeframe: From baseline to 8 weeks

Retention rate in %

Timeframe: 8 weeks

Feasibility of Intervention Measure (FIM) score

Timeframe: 8 weeks

Trial details

NCT IDNCT06143345

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Isolated Impaired Fasting Glucose trials

Plain-language summary

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Response rate in %

Timeframe: Baseline

Screening yield in %

Timeframe: Baseline

Enrolment rate in %

Timeframe: Baseline

Time to enrollment (mins)

Timeframe: Baseline

Intervention compliance in %

Timeframe: 8 weeks

Program costs (USD)

Timeframe: From baseline to 8 weeks

Staff time (mins)

Timeframe: From baseline to 8 weeks

Retention rate in %

Timeframe: 8 weeks

Feasibility of Intervention Measure (FIM) score

Timeframe: 8 weeks