Exercise for High Blood Sugar During Pregnancy

(TtM Trial)

Overseen By Jill Maples, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 11 days

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise timing affects blood sugar levels, sleep, and mood in pregnant individuals with high blood sugar issues, such as gestational diabetes. Participants will engage in 30 minutes of moderate exercise, like walking, either in the morning or late afternoon/evening, to determine if timing influences outcomes. It suits those pregnant with one baby and diagnosed with gestational diabetes or glucose intolerance. The goal is to discover if exercising at different times of the day can better manage these conditions. As an unphased trial, this study allows participants to contribute to valuable research that could enhance health recommendations for pregnant individuals with gestational diabetes.

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 prior data suggests that this exercise protocol is safe for pregnant individuals?

Research shows that walking at a moderate pace is well-tolerated by people with gestational diabetes (GDM). Studies have found that this type of exercise helps control blood sugar and is safe for pregnant individuals. For instance, walking every day effectively manages GDM without causing negative effects. Another study found that aerobic exercise like walking improved blood sugar levels and pregnancy outcomes. Overall, the evidence indicates that moderate walking is a safe and helpful way to manage high blood sugar during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of physical activity as a way to manage high blood sugar during pregnancy, also known as gestational diabetes. Unlike standard treatments like dietary changes, insulin, or oral medications, this approach investigates whether exercising at specific times of the day can make a difference in blood sugar control. The trial compares moderate-intensity walking or stepping either in the morning or the late afternoon/evening. By understanding the impact of exercise timing, researchers hope to offer a simple, non-invasive strategy that could complement existing treatments and improve outcomes for pregnant individuals.

What evidence suggests that this trial's physical activity timing could be effective for managing high blood sugar during pregnancy?

Research has shown that moderate exercise, such as walking, can help manage blood sugar levels in pregnant women with gestational diabetes or glucose intolerance. This trial will compare two different timing strategies for exercise: one group will perform moderate-intensity walking or stepping in the morning, while another group will do the same in the afternoon or evening. Specifically, one study found that this type of exercise improves blood sugar levels after meals and overall blood sugar control. Walking daily has proven effective in maintaining steady blood sugar levels for those with gestational diabetes. Another study demonstrated that just 20 minutes of walking after eating can lower blood sugar in these women. Overall, exercise offers a promising method to help control blood sugar during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Samantha Ehrlich, PhD

Principal Investigator

The University of Tennessee, Knoxville

Are You a Good Fit for This Trial?

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 meet the specific requirements needed to participate.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Moderate intensity walking or stepping

Trial Overview

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.

How Is the Trial Designed?

Group I: Morning physical activity first Experimental Treatment 1 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 first Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

University of Tennessee Graduate School of Medicine

Collaborator

Trials

17

Recruited

1,400+

Published Research Related to This Trial

Upper-extremity aerobic exercise is safe for pregnant women with gestational diabetes and does not induce uterine contractions, making it a viable option for managing glucose levels.

In a study of 20 gestational diabetic women, those who combined upper-extremity exercise with dietary therapy had significantly lower fasting and post-glucose challenge plasma glucose levels compared to those managed by diet alone, suggesting that this exercise could reduce the need for insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is exercise safe or useful for gestational diabetic women? Jovanovic-Peterson, L., Peterson, CM.[2019]

In a study of 68 women with gestational diabetes mellitus (GDM), those who engaged in higher levels of moderate-intensity physical activity (PA) had a significantly lower risk of experiencing adverse maternal-fetal outcomes, such as preterm birth and neonatal hypoglycemia.

Specifically, women in the control group (without adverse outcomes) reported an average of 7.5 MET-hours/week of moderate-intensity PA, compared to just 3.1 MET-hours/week in those with adverse outcomes, highlighting the potential protective effect of moderate exercise during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement Behavior during Pregnancy and Adverse Maternal-Fetal Outcomes in Women with Gestational Diabetes: A Pilot Case-Control Study. Camargo, SF., Camargo, JD., Schwade, D., et al.[2021]

A 10-week supervised home-based exercise program for sedentary obese pregnant women improved glucose tolerance and aerobic fitness, suggesting that regular exercise can be beneficial during pregnancy.

In contrast, the control group showed a deterioration in glucose tolerance, highlighting the potential health risks of inactivity during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised home-based exercise may attenuate the decline of glucose tolerance in obese pregnant women. Ong, MJ., Guelfi, KJ., Hunter, T., et al.[2022]

Exercise can effectively help manage blood glucose levels in pregnant women with gestational diabetes and those with type II diabetes, potentially reducing the need for insulin.

Tailored exercise programs, considering individual fitness levels and pregnancy constraints, are safe and beneficial, with moderate workouts being suitable for most women with gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise: an alternative therapy for gestational diabetes. Artal, R.[2010]

Moderate-intensity walking significantly improves post-meal blood glucose control in women with gestational diabetes mellitus (GDM) compared to being sedentary.

This study suggests that incorporating moderate-intensity walking after high-carbohydrate meals can be an effective strategy for managing blood glucose levels in women with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postprandial walking reduces glucose levels in women with gestational diabetes mellitus. Coe, DP., Conger, SA., Kendrick, JM., et al.[2018]

Engaging in recreational moderate to vigorous physical activity (MVPA) during midpregnancy is linked to a 27% lower risk of hyperglycemia, based on a study of 1437 pregnant women.

Women with a prepregnancy body mass index (BMI) under 25 kg/m² who participated in recreational MVPA had an even greater reduction in hyperglycemia risk, with a 48% lower risk compared to those who did not engage in such activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity during pregnancy and risk of hyperglycemia. Deierlein, AL., Siega-Riz, AM., Evenson, KR.[2021]

Aerobic exercise machines are beneficial for women with gestational diabetes, helping to improve blood glucose management and enhance maternal fitness without causing stress to the fetus.

Involving an exercise specialist to create personalized exercise programs increases the safety and effectiveness of workouts, while also monitoring the well-being of both mother and baby, making it a valuable addition to medical and dietary treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and glycemic responses of women with gestational diabetes to a moderately intense exercise program. Durak, EP., Jovanovic-Peterson, L., Peterson, CM.[2017]

A walking program during pregnancy, whether low-intensity or vigorous-intensity, is safe and beneficial for both mothers and their babies, as all participants delivered healthy infants.

The vigorous-intensity walking group showed a greater aerobic conditioning response, with significant decreases in oxygen consumption and carbon dioxide production during exercise, indicating improved cardiorespiratory fitness compared to the low-intensity group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking program of low or vigorous intensity during pregnancy confers an aerobic benefit. Ruchat, SM., Davenport, MH., Giroux, I., et al.[2012]

In a study involving five healthy pregnant women at 33 weeks of gestation, a single 30-minute session of moderate-intensity exercise significantly reduced the insulin response to a glucose load by 23% compared to a control day without exercise.

While the overall glucose tolerance (measured by the area under the glucose concentration curve) did not change, the improved insulin response suggests that moderate exercise can enhance metabolic health during the third trimester of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of prior exercise on oral glucose tolerance in late gestational women. Young, JC., Treadway, JL.[2019]

A partially home-based, moderate-intensity aerobic exercise program for women with gestational diabetes did not lead to significant reductions in blood glucose levels or hemoglobin A1C, indicating it may not be effective for glycemic control.

However, the exercise program was safe and resulted in a modest increase in cardiorespiratory fitness, suggesting potential benefits for overall health despite not impacting blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a partially home-based exercise program for women with gestational diabetes. Avery, MD., Leon, AS., Kopher, RA.[2022]

Exercise interventions during pregnancy significantly reduced gestational weight gain (GWG) by an average of 1.19 kg in women with overweight or obesity, based on a review of seven trials involving 1648 participants.

These interventions also led to a lower incidence of gestational diabetes (GD), with a risk ratio of 0.56, indicating a 44% reduction in the likelihood of developing GD compared to usual prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a structured exercise intervention in gestational weight gain in pregnant women with overweight and obesity: A systematic review with meta-analysis. Bernardo, DS., Carvalho, CB., Conde, M., et al.[2023]

The face-to-face (F2F) exercise intervention significantly increased exercise duration, daily steps, and motivational factors in pregnant women with gestational diabetes compared to standard care and home exercise, indicating its effectiveness in promoting physical activity.

The F2F group also showed lower postprandial blood glucose levels and delayed the need for insulin compared to the other groups, suggesting potential benefits for managing gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. Downs, DS., Dinallo, JM., Birch, LL., et al.[2023]

The intensive, medically supervised exercise intervention did not significantly reduce maternal fasting plasma glucose levels in obese pregnant women compared to routine prenatal care, indicating it may not improve glycemic control during pregnancy.

However, the exercise intervention was effective in reducing excessive gestational weight gain, with only 23.5% of women in the exercise group exceeding the recommended weight gain compared to 45.2% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Medically Supervised Pregnancy Exercise Intervention in Obese Women: A Randomized Controlled Trial. Daly, N., Farren, M., McKeating, A., et al.[2022]

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