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

Isolated Impaired Fasting Glucose Clinical Trial

Official title:

Effect of High-Intensity Interval Training on Fasting Hyperglycemia in People With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143345
• Other study ID #: STUDY00005855
• Secondary ID: UL1TR002378
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: Sathish Thirunavukkarasu, PhD
• Phone: 404-778-3771
• Email: sathish.thirunavukkarasu[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot randomized controlled trial of 20 physically inactive i-IFG adults aged 35-55 years with overweight or obesity. The investigators will test the effects of HIIT on fasting hyperglycemia, the pathophysiology of i-IFG, and continuous glucose monitoring (CGM) metrics compared with the control participants who will receive standard lifestyle recommendations. The research team will also examine the feasibility of conducting the study procedures and assess the acceptability of HIIT intervention.

Description:

This study is a 1:1 proof-of-concept randomized controlled trial (RCT) involving 34 physically inactive individuals aged 35-65 years who are overweight or obese and have isolated impaired fasting glucose (i-IFG). Participants will be identified through various sources and will undergo eligibility screening via phone calls. Those potentially eligible 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 and alanine aminotransferase analysis. Those 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 as the intervention participants. All participants will be asked to maintain their routine dietary habits throughout the study. Assessments at baseline and after eight weeks will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of glucose, insulin, and alanine aminotransferase. Additionally, intervention participants will complete an intervention acceptability questionnaire upon completing the intervention. The study outcomes will include between-group changes in CGM metrics and clinical measures, feasibility parameters, and intervention acceptability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion criteria:

1. Males and females aged 35-65 years

2. Any race or ethnicity

3. Overweight (body mass index [BMI] 25.0 to <30.0 kg/m2)25 or obese (BMI =30.0 kg/m2)

4. Diagnosed prediabetes

5. Physically inactive (<150 min of moderate-intensity or <75 min of vigorous-intensity aerobic physical activity/week)

6. Scoring =5 on the American Diabetes Association (ADA) risk test and

7. Will be residing in the same location until completion of the study

Exclusion criteria:

1. History of diabetes

2. No regular exercise training in the past 6 months

3. Pregnant women

4. Smokers

5. Taking medications known to affect glucose tolerance (e.g., steroids); and (6) 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.

Related Conditions & MeSH terms

• Isolated Impaired Fasting Glucose
• Prediabetic State

Intervention

Behavioral:
• High-Intensity Interval Training
HIIT with Spin sessions that will include a 5-min warm-up, then an interval-based workout phase with steady up-tempo cadences, sprints, and climbs (interspersed with recovery periods), followed by a 5-min cool down. The duration of the workout session will progress from 20 minutes during the initial familiarization week up to a maximum of 45 minutes. All participants will wear Polar H10 chest strap heart rate sensors to ensure adequate intensity throughout each session and be instructed daily on their target heart rate range, computed using the Karvonen method. Phone calls will be made to the participants a day before each session to remind them about their scheduled session. Also, a log of the number of exercise sessions attended by each participant will be kept, which will be reviewed regularly to ensure compliance with the intervention.
• Routine dietary habits and physical activity.
Control participants will be asked to maintain their routine dietary habits and physical activity.

Device:
• Continuous glucose monitoring (CGM) (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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Center for Advancing Translational Sciences (NCATS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose in mg/dl	Change in fasting plasma glucose from baseline to 8 weeks will be compared between study groups	8 weeks
Primary	Early-phase insulin secretion	Early-phase insulin secretion will be measured using the insulinogenic index ([I30-I0]/[G30-G0]) with insulin and glucose levels at 0 and 30 min of the OGTT. Change in IGI from baseline to 8 weeks will be compared between study groups	8 weeks
Primary	Hepatic insulin resistance	Hepatic insulin resistance will be assessed using HIRI (glucose 0-30[AUC] x insulin 0-30[AUC]). Results will be compared between study groups.	8 weeks
Primary	Fasting glucose in mg/dl on post-exercise day	The CGM device, Dexcom G6 Pro CGM system (DexCom, Inc., San Diego, CA), will be used to measure this outcome. The difference in mean CGM fasting glucose (one-hour mean following 8-10 hours of fasting) on post-exercise day will be compared between study groups	Daily for 8 weeks
Secondary	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
Secondary	BMI in kg/m2	Change in BMI from baseline to 8 weeks will be compared between study groups	8 weeks
Secondary	Waist circumference in cm	Change in waist circumference from baseline to 8 weeks will be compared between study groups	8 weeks
Secondary	Waist-to-hip ratio	Change in waist-to-hip ratio from baseline to 8 weeks will be compared between study groups	8 weeks
Secondary	Systolic blood pressure in mmHg	Change in systolic BP from baseline to 8 weeks will be compared between study groups	8 weeks
Secondary	Diastolic blood pressure in mmHg	Change in diastolic BP from baseline to 8 weeks will be compared between study groups	8 weeks
Secondary	Time in range (TIR) of normoglycemia (70 to <110 mg/dl) overnight	The CGM device, Dexcom G6 Pro CGM system (DexCom, Inc., San Diego, CA) will be used to measure this outcome. Time in range (TIR) of normoglycemia (70 to <110 mg/dl) overnight measured by CGM will be compared between the intervention and control groups.	Through study completion, an average of 8-10 weeks
Secondary	Coefficient of variation in glucose levels	The CGM device, Dexcom G6 Pro CGM system (DexCom, Inc., San Diego, CA) will be used to measure this outcome. Coefficient of variation in glucose levels (overnight and overall) will be compared between study groups.	Through study completion, an average of 8-10 weeks
Secondary	Response rate in %	Defined as the proportion of individuals responding to the invitation sent via the Epic database	Baseline
Secondary	Screening yield in %	Defined as the proportion of screened individuals meeting eligibility criteria	Baseline
Secondary	Enrollment rate in %	Defined as the proportion of eligible individuals who enroll in the study	Baseline
Secondary	Cost in USD	Study expenditures in USD	8-10 weeks
Secondary	Retention rate in %	Defined as the proportion of enrolled participants who complete the study	8 weeks
Secondary	Intervention acceptability score	Intervention acceptability will be measured using a questionnaire with answers to questions recorded on a likert scale of 1-5: 1, Strongly disagree; 2, Disagree; 3, Neutral; 4, Agree; 5, Strongly agree. The minimum score will be 10 and the maximum score will be 50.	8 weeks