Study on HIIT and Time-Restricted Eating for Type 2 Diabetes Risk

This study is looking at how two approaches, High-intensity interval training (HIIT) and Time-restricted eating (TRE), affect the risk of developing Type 2 Diabetes in adolescents and young adults. HIIT involves short bursts of intense exercise, while TRE means eating all your meals within a specific 10-hour window each day. Researchers want to see if these interventions can help improve health markers related to heart disease and diabetes. You might be able to join if you are between 14 and 30 years old and are overweight or have obesity. The study will measure your weight, height, and Body Mass Index (BMI) to see if these interventions are successful. The current status of this study is unclear.

Study design
This is a randomized controlled trial planning to enroll 40 participants. It compares two behavioral interventions: High-intensity interval training (HIIT) and Time-restricted eating (TRE).
What's involved
Participants in the HIIT group will exercise on a stationary bicycle 3 times a week for 4 weeks. Participants in the TRE group will eat all their calories within a 10-hour window daily for 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your weight, height, and BMI will be measured at the beginning of the study and again after 4 weeks of intervention.

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NCT07215533

Effects of HIIT vs. TRE on Type 2 Diabetes Risk

Recruiting
NAAges 14–30InterventionalPrevention
Syracuse University
~40 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:High-intensity interval trainingTime-restricted eating

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight (kg)
Measured over Baseline and after 4 weeks of intervention
+16 more outcomes measured
Obesity and Type 2 Diabetes
Metabolic Diseases
High-intensity Interval Training
Time-restricted Eating
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

Adolescents (age 14-17 years old with sex- and race-specific BMI percentile ≥85th) and young adults with overweight and obesity (age 18 to 30 years old with BMI ≥25 kg/m2)

Exclusion

Chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV).
Have taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti- hypertensive, endocrinologic (e.g., thyroid, insulin, etc.), emotional/psychotropic (e.g., Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications (anabolic steroids).
Have a pacemaker.
  • Weight (kg)Baseline and after 4 weeks of intervention

    Weight is measured in kilograms (kg) using a calibrated digital scale.

  • Height (cm)Baseline and after 4 weeks of intervention

    Height is measured in centimeters (cm) using a wall-mounted stadiometer.

  • Body Mass Index (BMI)Baseline and after 4 weeks of intervention

    Weight and height will be combined to report BMI in kg/m².

  • Waist Circumference and Hip CircumferenceBaseline and after 4 weeks of intervention

    Waist and hip circumferences are measured while participants stand straight with their arms extended outward. A non-elastic tape measure is wrapped around the waist and hip, and measurements are taken to the nearest centimeter (cm).

  • Blood Lipid ProfileBaseline and after 4 weeks of intervention

    Blood lipid profile, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), and fasting glucose (FG) are measured in milligrams per deciliter (mg/dL) using the Cholestech LDX Analyzer. Blood samples are obtained via fingerstick, with the first drop wiped away and the second drop collected for analysis. Participants stand or sit comfortably during collection. After blood collection, the site is cleaned and covered with gauze and a bandage as needed. This procedure is minimally invasive and typically causes little discomfort.

  • Blood PressureBaseline and after 4 weeks of intervention

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are measured in millimeters of mercury (mmHg), and resting heart rate (RHR) is measured in beats per minute (bpm) using an automated blood pressure monitor. Participants sit quietly for five minutes with minimal movement prior to measurement. A cuff is placed on the right upper arm (bicep area), and the monitor initiates inflation, deflation, and reinflation cycles. Participants are instructed not to move during the measurement process. All equipment is disinfected before and after each use with antiviral, antibacterial, and antifungal disposable wipes by a researcher wearing gloves.

  • Carotid-Femoral Pulse Wave VelocityBaseline and after 4 weeks of intervention

    Carotid-femoral pulse wave velocity (PWV), a preclinical marker of cardiovascular disease (CVD), is measured in meters per second (m/s) using applanation tonometry (SphygmoCor, AtCor Medical). Participants are positioned supine on a padded exam table after resting quietly for approximately five minutes. Brachial blood pressure is measured in millimeters of mercury (mmHg) using an automated cuff device. Pressure waveforms are recorded at the carotid artery (neck) and femoral artery (upper leg) using a handheld tonometer. The time delay between carotid and femoral pulse waves is used to calculate PWV, an indicator of arterial stiffness. The procedure is non-invasive and typically requires approximately five minutes to complete.

  • Glucose (mg/dL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose (mg/dL).

  • Insulin (μIU/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of insulin (μIU/mL).

  • C-peptide (ng/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-peptide (ng/mL).

  • Total glucagon-like peptide-1 (GLP-1) (pmol/L)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of total glucagon-like peptide-1 (GLP-1) (pmol/L).

  • Glucose-dependent insulinotropic polypeptide (GIP) (pg/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).

  • Leptin (ng/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of leptin (ng/mL).

  • Adiponectin (μg/mL)Time Frame: Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of adiponectin (μg/mL).

  • Ghrelin (pg/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of ghrelin (pg/mL).

  • C-reactive protein (CRP) (mg/L)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-reactive protein (CRP) (mg/L).

  • Interleukin-6 (IL-6) (pg/mL)Baseline and after 4 weeks of intervention

    After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of