Status:
RECRUITING
Time to Move in Pregnancy Hyperglycemia
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
University of Tennessee Graduate School of Medicine
Conditions:
GDM
Physical Activity
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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)...
Detailed Description
Research participants will: 1. Exercise according to a schedule provided by the study for an 11-day period. They will complete either no exercise or 30 minutes of walking/stepping (e.g., stepping in ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06125704
Start Date
December 6 2023
End Date
December 1 2025
Last Update
March 5 2025
Active Locations (1)
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1
The University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920