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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{5 7 11 12 13}

Research Team

Samantha Ehrlich, PhD

Principal Investigator

The University of Tennessee, Knoxville

Eligibility 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 meet the specific requirements needed to participate.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a partially home-based exercise program for women with gestational diabetes. [2022]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Medically Supervised Pregnancy Exercise Intervention in Obese Women: A Randomized Controlled Trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Physical and glycemic responses of women with gestational diabetes to a moderately intense exercise program. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Physical activity during pregnancy and risk of hyperglycemia. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Walking program of low or vigorous intensity during pregnancy confers an aerobic benefit. [2012]

8. Canada pubmed.ncbi.nlm.nih.gov

Postprandial walking reduces glucose levels in women with gestational diabetes mellitus. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Supervised home-based exercise may attenuate the decline of glucose tolerance in obese pregnant women. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Movement Behavior during Pregnancy and Adverse Maternal-Fetal Outcomes in Women with Gestational Diabetes: A Pilot Case-Control Study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Is exercise safe or useful for gestational diabetic women? [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

The effect of prior exercise on oral glucose tolerance in late gestational women. [2019]

13. England pubmed.ncbi.nlm.nih.gov

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