Time to Move in Pregnancy Hyperglycemia

Launched by THE UNIVERSITY OF TENNESSEE, KNOXVILLE · Nov 3, 2023

Keywords

ClinConnect Summary

The "Time to Move in Pregnancy Hyperglycemia" clinical trial is looking at how the timing of physical activity affects blood sugar levels in pregnant women with gestational diabetes or glucose intolerance. Specifically, the study will compare the effects of 30 minutes of moderate exercise, like walking, done in the morning shortly after breakfast versus in the late afternoon or evening after dinner. Researchers want to see not only how these different times affect blood sugar throughout the day but also how they might influence sleep and mood.

To participate in this study, women aged 18 to 40 who are currently pregnant and diagnosed with gestational diabetes or glucose intolerance may be eligible. Participants will need to be able to communicate in English and complete surveys. During the trial, they can expect to follow a structured exercise schedule and provide information about their blood sugar levels, sleep, and mood. This research could help improve understanding of how exercise timing impacts health during pregnancy.

Gender

FEMALE

Eligibility 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).