Exercise for High Blood Sugar During Pregnancy
(TtM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Tennessee, Knoxville
Must not be taking: Metformin, Corticosteroids, Antipsychotics, others
Disqualifiers: Type I/II diabetes, PCOS meds, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that participants not be on daily medications that alter insulin resistance or metabolic profiles, such as metformin, corticosteroids, or anti-psychotics. If you are taking these medications, you would need to stop them to participate.
What data supports the effectiveness of the treatment Moderate intensity walking or stepping, Moderate intensity walking, Stepping exercise for high blood sugar during pregnancy?
Research shows that moderate-intensity exercise, like walking or stepping, can help manage blood sugar levels in pregnant women with gestational diabetes. These exercises improve blood glucose management and increase fitness without causing stress to the baby.
12345Is moderate-intensity exercise safe during pregnancy?
Research shows that moderate-intensity exercise, like walking, is safe for pregnant women and can be beneficial for both the mother and baby. Studies indicate that it does not negatively affect body weight gain during pregnancy and is associated with healthy deliveries.
678910How does exercise differ from other treatments for high blood sugar during pregnancy?
Exercise is a unique treatment for high blood sugar during pregnancy because it can improve glucose tolerance and reduce the need for insulin by using muscle contractions to help transport glucose. Unlike traditional treatments that rely on diet or insulin, exercise can be tailored to individual needs and is safe for both the mother and fetus when done moderately.
57111213Eligibility Criteria
This trial is for pregnant individuals aged 18-40 with gestational diabetes or glucose intolerance, carrying a single baby without significant abnormalities. Participants must have been diagnosed after 24 weeks of pregnancy and be comfortable communicating in English without a translator.Inclusion Criteria
Your blood sugar level when you haven't eaten should be below 95 mg/dL.
I am pregnant with one baby, and tests show low risk for birth defects.
I am between 18 and 40 years old.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants engage in a randomized crossover trial involving 30 minutes of moderate intensity walking or stepping at specified times over an 11-day period.
11 days
Daily monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Participant Groups
The study tests the effects of timing on physical activity—specifically, whether walking or stepping for 30 minutes in the morning versus late afternoon/evening has different impacts on blood sugar levels, sleep quality, and mood during pregnancy.
2Treatment groups
Experimental Treatment
Group I: Morning physical activity firstExperimental Treatment1 Intervention
Randomized to complete 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 9 and 10.
Group II: Afternoon/evening physical activity firstExperimental Treatment1 Intervention
Randomized to complete 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 9 and 10.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Tennessee Medical CenterKnoxville, TN
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Who Is Running the Clinical Trial?
The University of Tennessee, KnoxvilleLead Sponsor
University of Tennessee Graduate School of MedicineCollaborator
References
Effects of a partially home-based exercise program for women with gestational diabetes. [2022]To examine the effectiveness of a partially home-based, moderate-intensity aerobic exercise program for women with gestational diabetes.
Effectiveness of a structured exercise intervention in gestational weight gain in pregnant women with overweight and obesity: A systematic review with meta-analysis. [2023]To assess the effectiveness of exercise interventions during pregnancy in managing gestational weight gain (GWG), excessive GWG, gestational diabetes (GD), hypertensive disorders, 2-h post-oral glucose tolerance test (OGTT), and birth weight in pregnant women with overweight/obesity (OW/OB).
A Medically Supervised Pregnancy Exercise Intervention in Obese Women: A Randomized Controlled Trial. [2022]To evaluate whether an intensive, medically supervised exercise intervention improved maternal glycemia and gestational weight gain in obese pregnant women when compared with routine prenatal care.
Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. [2023]Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM).
Physical and glycemic responses of women with gestational diabetes to a moderately intense exercise program. [2017]Aerobic exercise machines are becoming more popular. Their use by women with gestational diabetes is reported, and their benefits in improving blood glucose management and in increasing maternal fitness without undue stress to the fetus are substantiated. Of equal benefit is the use of an exercise specialist to prescribe an individual exercise program, to increase the safety and effectiveness of the workout, to monitor maternal and fetal well-being, to record relevant data, and to provide feedback and information to the patient about the exercise session. The use of exercise specialists in the clinical setting should prove a useful adjunct to medical and dietary regimens for the woman with gestational diabetes.
Physical activity during pregnancy and risk of hyperglycemia. [2021]To determine the association between moderate and vigorous physical activities (MVPA) during midpregnancy and the risk of hyperglycemia.
Walking program of low or vigorous intensity during pregnancy confers an aerobic benefit. [2012]Walking is the most popular activity during pregnancy and may confer an aerobic benefit. However, the minimum intensity threshold of a maternal walking program for an aerobic conditioning response is unknown. The purpose was to examine the effect of a walking program of a low-intensity (LI, 30% heart rate reserve, HRR) or vigorous-intensity (VI, 70%HRR) on maternal cardiorespiratory responses to a standard submaximal treadmill test. Normal weight pregnant women were randomized at study entry (16-20 weeks of gestation) to the LI (n=23) or VI (n=21) walking program, with nutritional control. Participants performed a steady-state treadmill exercise test at their prescribed intensity pre- and post-intervention (34-36 weeks) to evaluate changes in cardiorespiratory responses. Increasing body mass due to pregnancy was similar between the groups throughout the study. From pre- to post-intervention, relative (mL kg - 1 min - 1) VO2 and VCO2 during steady-state submaximal treadmill exercise did not change in the LI group but decreased in the VI group (- 1.25±2.71, p=0.02 and - 1.50±2.64, p=0.005, respectively). Both groups presented increases in oxygen pulse (p≤0.002). Our results showed that the energy cost of walking was not affected by the increase in maternal body weight in the LI group and was decreased in the VI group, suggesting an aerobic conditioning response in both groups, although the VI group presented a greater response. All women presented similar body mass throughout the intervention and delivered healthy babies, indicating that a prenatal walking program of low or vigorous intensity, combined with healthy eating habits, is safe and beneficial to the mother and fetus.
Postprandial walking reduces glucose levels in women with gestational diabetes mellitus. [2018]The purpose of this study was to investigate blood glucose changes, as measured by a continuous glucose monitoring system, that occur in women with gestational diabetes mellitus (GDM) following an acute bout of moderate-intensity walking after consuming a high-carbohydrate/low-fat meal. This study found that moderate-intensity walking induced greater postprandial glucose control compared with sedentary activity and it appears that moderate-intensity activity may be used to reduce postprandial glucose levels in women with GDM.
Supervised home-based exercise may attenuate the decline of glucose tolerance in obese pregnant women. [2022]The significant deterioration of insulin sensitivity and glucose tolerance during pregnancy can have serious health implications for both the pregnant woman and her baby. Although it is well established that regular exercise benefits insulin sensitivity in the nonpregnant population, the effect on glucose tolerance in obese pregnant women is not known. The purpose of this study was to investigate the effect of a supervised 10-week, home-based, exercise programme, beginning at week 18 of gestation, on glucose tolerance and aerobic fitness in previously sedentary obese women.
Movement Behavior during Pregnancy and Adverse Maternal-Fetal Outcomes in Women with Gestational Diabetes: A Pilot Case-Control Study. [2021]Gestational diabetes mellitus (GDM) is a major complication in pregnancy. GDM is associated with a higher risk for adverse maternal-fetal outcomes. Associations between movement behavior, including physical activity (PA) and sedentary behavior (SB), and maternal-fetal outcomes are still unclear. The objective of this study was to investigate associations between movement behavior and adverse maternal-fetal outcomes in women with GDM. A total of 68 women with GDM (20-35 weeks, 32.1 ± 5.8 years) were included in this pilot case-control study. The cases were defined by the presence of an adverse composite maternal-fetal outcome (preterm birth, newborn large for gestational age, and neonatal hypoglycemia). Controls were defined as no adverse maternal-fetal outcome. PA intensities and domains, steps/day (pedometer), and SB were analyzed. A total of 35.3% of participants showed adverse maternal-fetal outcomes (n = 24). The controls showed a higher moderate-intensity PA level than the cases (7.5, 95%CI 3.6-22.9 vs. 3.1, 95%CI 0.4-10.3 MET-h/week; p = 0.04). The moderate-intensity PA level was associated with a lower risk for adverse maternal-fetal outcomes (OR 0.21, 95%CI 0.05-0.91). No significant associations were observed for other PA and SB measures (p > 0.05). In conclusion, moderate-intensity PA during pregnancy seems to have a protective role against adverse maternal-fetal outcomes in women with GDM.
Is exercise safe or useful for gestational diabetic women? [2019]The mainstay of management of the gestational diabetic woman is dietary manipulation to achieve and maintain normoglycemia. If normoglycemia cannot be sustained by diet alone, then insulin therapy is initiated. We instituted a series of studies to observe the value and safety of a cardiovascular fitness program to improve glucose tolerance in gestational diabetic women. We first evaluated the safety for pregnant women of five aerobic exercise machines by observing the effect of these different forms of exercise on uterine activity during the third trimester. We found that upper-extremity exercise produced no uterine contractions, but lower-extremity exercise tended to produce contractions. Upper-extremity exercise, in addition to dietary therapy, was then assigned to 10 gestational diabetic women who were matched for amount of glucose intolerance to 10 gestational diabetic women managed by diet alone. The mean fasting plasma glucose +/- SD after 6 wk was 4.87 +/- 0.34 mM in the diet group versus 3.89 +/- 0.37 mM in the diet-plus-exercise group. The mean postglucose challenge in the diet group was 10.40 +/- 0.16 mM versus 5.9 +/- 1.1 mM in the diet-plus-exercise group. Thus, upper-arm exercise may provide a useful treatment option for gestational diabetes and may obviate the need for insulin.
The effect of prior exercise on oral glucose tolerance in late gestational women. [2019]Glucose tolerance deteriorates over the course of a normal human pregnancy as a result of increased peripheral insulin resistance. In contrast, physical exercise has been shown to improve glucose tolerance and blunt the insulin response to a glucose load in insulin-resistant individuals. The purpose of this study was to determine the effect of exercise on glucose tolerance and the insulin response in healthy women during the third trimester of pregnancy (33 weeks of gestation). Five subjects underwent oral glucose tolerance tests (a) 30 min following a 30-min exercise bout on a cycle ergometer at a relative intensity of 50% maximal aerobic capacity, and (b) on a control day without prior exercise. The area under the glucose concentration curve was not different between trials, while the area under the insulin concentration curve was decreased by 23% in the exercise trial compared with the control trial (P less than 0.05). These results suggest that the insulin response to a glucose load is improved in late gestational women by a single bout of moderate intensity exercise.
Exercise: an alternative therapy for gestational diabetes. [2010]Exercise can play a significant role in managing blood glucose levels in women who develop gestational diabetes and in women with type II diabetes who become pregnant. Because contracting muscles help stimulate glucose transport, exercise can help women control gestational diabetes without insulin. After constraints typical of pregnancy are taken into account such as soft-tissue laxity and fetal status exercise program can be tailored to the individual needs of patients. Although fit, active women may tolerate more strenuous exercise, relatively sedentary women may benefit most from non-weight-bearing exercises. Moderate workouts appear to be safe for most women who have gestational diabetes.