Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Purpose of the Study: This study is to learn more about how exercising at different times of the day (morning versus evening) affects metabolism of glucose in the body, sleep, activity outside of exercise, and other factors. Procedures: * 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG). * If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks: * Baseline condition of NO exercise * Morning exercise for 3 days in a row * Evening exercise for 3 days in a row * You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a traditional diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time. * You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels. * You will undergo one x-ray scan to measure your level of body fat. * You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study. * You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study. * You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples). * You will be asked to complete a procedure called a hyperinsulinemic-euglycemic clamp where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• Age 20-40 years.

• Biologically female participants with regular menstruation

• Body mass index (BMI) ≥ 30.0 to ≤ 40.0 kg/m2

• Prediabetes as defined by the American Diabetes Association (HgbA1c ≥ 5.7% to \< 6.5% or fasting glucose ≥ 100 to \< 126 mg/dL)

• Physically inactive (\< 100 min/wk of regular exercise)

• No contraindications to exercise or limitations on ability to be physically active

• Weight stable (weight change \< 5kg in past 3 months)

• Not currently pregnant or lactating, not pregnant within the past 6 months or planning to become pregnant in the next 6 months.

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Contact Information
Primary
Rebecca Rosenberg, DO
rebecca.rosenberg@cuanschutz.edu
5034427062
Backup
Seth Creasy, PhD
seth.creasy@cuanschutz.edu
720-848-0000
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 25
Treatments
Experimental: Crossover - AM first
Crossover design with AM exercise first
Experimental: Crossover - PM first
Crossover design with PM exercise first
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov