Time to Move in Pregnancy Hyperglycemia
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.
Conditions:
🦠 GDM 🦠 Physical Activity 🦠 Hyperglycemia 🦠 Glucose Intolerance 🦠 Circadian Rhythm 🦠 Exercise
🗓️ Study Start (Actual) 6 December 2023
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Knoxville, Tennessee, United States

📋 Eligibility Criteria

Description

  • 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).
Ages Eligible for Study: 18 Years to 40 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 October 2023
  • First Submitted that Met QC Criteria 3 November 2023
  • First Posted 9 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 January 2024
  • Last Update Posted 11 January 2024
  • Last Verified January 2024