High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: Protocol for a Proof-of-Concept Randomized Controlled Trial.

Abstract

Background: Standard lifestyle interventions have shown limited efficacy in preventing type 2 diabetes among individuals with isolated impaired fasting glucose (i-IFG). Hence, tailored intervention approaches are necessary for this high-risk group.

Objective: This study aims to (1) assess the feasibility of conducting a high-intensity interval training (HIIT) study and the intervention acceptability among individuals with i-IFG, and (2) investigate the preliminary efficacy of HIIT in reducing fasting plasma glucose levels and addressing the underlying pathophysiology of i-IFG.

Methods: This study is a 1:1 proof-of-concept randomized controlled trial involving 34 physically inactive individuals (aged 35-65 years) who are overweight or obese and have i-IFG. Individuals will undergo a 3-step screening procedure to determine their eligibility: step 1 involves obtaining clinical information from electronic health records, step 2 consists of completing questionnaires, and step 3 includes blood tests. All participants will be fitted with continuous glucose monitoring devices for approximately 80 days, including 10 days prior to the intervention, the 8-week intervention period, and 10 days following the intervention. Intervention participants will engage in supervised HIIT sessions using stationary "spin" cycle ergometers in groups of 5 or fewer. The intervention will take place 3 times a week for 8 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. All participants will receive instructions to maintain a eucaloric diet throughout the study. Baseline and 8-week assessments will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of fasting plasma glucose, 2-hour plasma glucose, and fasting insulin. Primary outcomes include feasibility parameters, intervention acceptability, and participants' experiences, perceptions, and satisfaction with the HIIT intervention, as well as facilitators and barriers to participation. Secondary outcomes comprise between-group differences in changes in clinical measures and continuous glucose monitoring metrics from baseline to 8 weeks. Quantitative data analysis will include descriptive statistics, correlation, and regression analyses. Qualitative data will be analyzed using framework-driven and thematic analyses.

Results: Recruitment for the study is scheduled to begin in February 2025, with follow-up expected to be completed by the end of September 2025. We plan to publish the study findings by the end of 2025.

Conclusions: The study findings are expected to guide the design and execution of an adequately powered randomized controlled trial for evaluating HIIT efficacy in preventing type 2 diabetes among individuals with i-IFG.

Trial registration: Clinicaltrials.gov NCT06143345; https://clinicaltrials.gov/study/NCT06143345.

International registered report identifier (irrid): PRR1-10.2196/59842.