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

NCT06292000 | Withdrawn DMC

• 1 other identifier: 23-1721
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes; Obesity; Inactivity/Low Levels of Exercise

Keywords

exercise; sleep; time of day; insulin sensitivity; prediabetes; type 2 diabetes; physical activity; melatonin

Outcome Measures

Primary Outcomes (1)

• Peripheral insulin sensitivity

  Measured via hyperinsulinemic euglycemic clamp

  Monthly for three months

Secondary Outcomes (5)

• Free Living Glucose

  1 week time frame every month for 3 months

• Melatonin offset

  Monthly for three months

• AM Cortisol

  Monthly for three months

• Physical activity and sedentary behavior

  1 week time frame every month for 3 months

• Sleep outcomes

  1 week time frame every month for 3 months

Study Arms (2)

Crossover - AM first

EXPERIMENTAL

Crossover design with AM exercise first

Behavioral: AM Exercise; Behavioral: PM Exercise

Crossover - PM first

EXPERIMENTAL

Crossover design with PM exercise first

Behavioral: AM Exercise; Behavioral: PM Exercise

Interventions

PM Exercise BEHAVIORAL

Evening (9-12 hours after habitual wake time) aerobic exercise at 70% age predicted HR max for 45 minutes

Crossover - AM first; Crossover - PM first

AM Exercise BEHAVIORAL

Morning (0-3 hours from habitual wake time) aerobic exercise at 70% age predicted HR max for 45 minutes

Crossover - AM first; Crossover - PM first

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History or symptoms suggestive of cardiovascular disease or congestive heart failure
• Diastolic blood pressure \> 100 mmHg, systolic blood pressure \> 160 mmHg, or resting heart rate \> 100 bpm
• History of type 1 or type 2 DM (or fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5% on screening labs)
• Current use of medications that effect SI (oral steroids, metformin, GLP1 receptor agonists, etc).
• Chronic kidney disease (CKD, stage 4 or higher)
• TSH, electrolytes, hematocrit, white blood cell count, or platelets significantly outside the normal reference range on screening labs
• Triglycerides \> 400 or LDL \> 200 on screening labs
• Clinically significant abnormality on resting ECG, presence, or history of any other metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in exercise,
• History of obstructive sleep apnea, primary insomnia, night-time shiftwork, rotating work, or other atypical sleep patterns.
• Current or recent (within 1 month) zero or very low carbohydrate diet (\< 10% daily calories from carbohydrates).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Motor Activity; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 4, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)