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Search / Trial NCT06292000

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

Launched by UNIVERSITY OF COLORADO, DENVER · Mar 1, 2024

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Exercise Sleep Time Of Day Insulin Sensitivity Prediabetes Type 2 Diabetes Physical Activity Melatonin

ClinConnect Summary

This clinical trial is exploring how exercising in the morning or evening affects how our bodies process sugar, particularly for adults who are at risk of developing diabetes (a condition called prediabetes) and are not very active. The study will help researchers understand if the time of day we exercise can influence our metabolism, sleep quality, and overall health.

To participate, you need to be between the ages of 20-40, have a body mass index (BMI) between 30 and 40, and meet specific health criteria related to prediabetes. If you qualify, you'll go through a few steps, including some health screenings and then try both morning and evening exercise routines over a few weeks. You’ll also follow a specific diet during this trial and wear monitors to track your activity and sleep. The study aims to gather valuable information about how different exercise times might help improve health, especially for those struggling with weight and inactivity.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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).

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported