Effects of Exercise Timing on Blood Sugar in Pregnant Women with Gestational Diabetes
The Time to Move Randomized Crossover Trial
This study is testing whether walking in the morning or evening helps pregnant women with gestational diabetes better manage their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | The University of Tennessee, Knoxville Academic / other |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06125704 on ClinicalTrials.gov |
What this trial studies
This randomized controlled crossover trial involves 36 pregnant individuals diagnosed with gestational diabetes or glucose intolerance. Participants will engage in 30 minutes of moderate-intensity walking either in the morning or late afternoon/evening over an 11-day period, while their glucose levels are monitored using continuous glucose monitors. The study aims to assess how the timing of physical activity affects glucose levels throughout the day, as well as its potential impact on sleep and mood. Participants will also document their dietary intake and complete daily surveys regarding their eating and sleeping patterns.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-40 with a diagnosis of gestational diabetes or glucose intolerance.
Not a fit: Patients who are not pregnant or those with significant pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize physical activity timing to better manage blood sugar levels in pregnant women with gestational diabetes.
How similar studies have performed: Other studies have shown promising results regarding the impact of physical activity on glucose management, but this specific timing approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria * Singleton, viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy * Age 18-40 years (at recruitment) * Comfortable communicating with study staff in English and completing study surveys in English (i.e., no translator needed) * Identified as Gestational Glucose Intolerance (GGI) and a 3-hr 100g OGTT for Gestational Diabetes Mellitus (GDM) performed ≥ 24 weeks (i.e., GGI or GDM), or GDM by the one step procedure or a 1-hr 50-g glucose challenge test (GCT) ≥ 180 mg/dl performed ≥ 24 weeks Identification of GGI 1-hr 50-g GCT (non-fasting), with plasma glucose at 1-hr ≥ 130 mg/dL Identification of GDM by the two-step procedure Identified as GGI, followed by a 3-hr 100g OGTT at ≥ 24 weeks after an overnight fast, with at least two of four plasma glucose values meeting or exceeding: * Fasting: 95 mg/dL * 1-hr: 180 mg/dL * 2-hr: 155 mg/dL * 3-hr: 140 mg/dl Identification of GDM by the one-step procedure 75-g OGTT at ≥ 24 weeks after an overnight fast, with at least one plasma glucose value meeting or exceeding: * Fasting: 92 mg/dL * 1-hr: 180 mg/dL * 2-hr: 153 mg/dL Identification of GDM by 1-hr 50-g GCT 1-hr 50-g GLT (non-fasting), with plasma glucose at 1-hr ≥ 180 mg/dL at ≥ 24 weeks Exclusion Criteria * Indication that physical activity is or should be limited in the current pregnancy * Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy * Current use of daily medications known to alter insulin resistance and/or metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics) * Current use of medication for polycystic ovarian syndrome (PCOS) (i.e., history of PCOS okay as long as she is not currently taking medication for PCOS) * Condition or circumstance that would preclude their ability to follow a strict, time-based study protocol (e.g., psychiatric illness).
Where this trial is running
Knoxville, Tennessee
- The University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Samantha Ehrlich, PhD — The University of Tennessee, Knoxville
- Study coordinator: Samantha Ehrlich, PhD
- Email: sehrlic1@utk.edu
- Phone: (865) 315-7880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.