Time to Move in Pregnancy Hyperglycemia (NCT06125704) | Clinical Trial Compass
CompletedNot Applicable
Time to Move in Pregnancy Hyperglycemia
United States39 participantsStarted 2023-12-06
Plain-language summary
This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will:
1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle.
2. Explore the potential effects of the timing of PA on sleep and mood state.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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 kn…