AzTrials
AzTrials

Pregestational DiabetesNCT07250698

Glucose Control in Type 2 Diabetes in Pregnancy

A study testing Exercise in people with Pregestational Diabetes and Type 2 Diabetes, run by Eastern Virginia Medical School at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the effect of physical activity on glucose control in pregnant patients with pregestational Type 2 diabetes. The main question it seeks to answer is "will physical activity following a meal improve blood sugar control in pregnant women with Type 2 diabetes?" Researchers… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pregestational Diabetes, Type 2 Diabetes
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Dec 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton gestation
  • Known diagnosis of Type 2 diabetes OR meets new diagnosis of Type 2 diabetes in the first trimester (up to 13 weeks and 6 days)
  • Age ≥18 and <50 years
  • Gestational age <32 weeks 0 days gestation

Who cannot join

  • Non-English as the primary language
  • Inability to participate in 20 minutes of walking at a time
  • Known or suspected fetal anomaly or aneuploidy
  • Prisoners
  • Management of diabetes outside of study location

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marwan Ma'ayeh, MD contact

757-446-7900

MaayehMG@odu.edu

United States1 site

  • Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Dominion University

    Norfolk, Virginia, 23507

    Marwan Ma'ayeh, MD, 757-446-7900, MaayehMG@odu.edu

Other trials in United States

About this study

Official title: Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy

The goal of this clinical trial is to evaluate the effect of physical activity on glucose control in pregnant patients with pregestational Type 2 diabetes. The main question it seeks to answer is "will physical activity following a meal improve blood sugar control in pregnant women with Type 2 diabetes?" Researchers will compare the glucose control of two groups: one that walks for 20 minutes after each meal, and one that does not.

Being tested
Exercise
Keywords
exercise, continuous glucose monitoring
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    This intervention consists of instructions to walk for 20 minutes after each meal.

Study groups in NCT07250698
Study groupRoleWhat they receive
Post-prandial walkActive comparatorParticipants in this arm of the study will be instructed to walk for 20 minutes after each meal (breakfast, lunch, and dinner). They will also be given a continuous glucose monitor and a FitBit, to wear throughout their participation in the study.
Receives: Behavioral: Exercise
Standard of CareNo interventionParticipants in this arm will be given the regular counseling on the importance of exercise during pregnancy, but not instructed to walk after each meal. They will receive a continuous glucose monitor and FitBit to wear throughout their participation in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Glucose Time in Range

    Our primary outcome is the time in range (via CGM data) during the management of Type 2 diabetes in pregnancy between 34 and 36 weeks gestation.

    Measured: Between 34 and 36 weeks gestation.

Secondary outcomes (44)

  1. Duration of postprandial walk

    Duration of postprandial walk (in minutes)

    Measured: From enrollment to delivery, an average of 6 months

  2. Sleep duration

    Amount of time spent sleeping

    Measured: From enrollment to delivery, an average of 6 months

  3. Baseline heart rate

    Heart rate when not exercising

    Measured: From enrollment to delivery, an average of 6 months

  4. Maximal heart rate during walks

    Maximal heart rate during postprandial walks

    Measured: From enrollment to delivery, an average of 6 months

  5. Frequency of aerobic exercise per week

    Number of times a participant engages in aerobic exercise each week

    Measured: From enrollment to delivery, an average of 6 months

  6. Mean glucose level

    Average blood sugar level

    Measured: From enrollment to delivery, an average of 6 months

  7. Blood Glucose Excursions

    Changes in blood glucose

    Measured: From enrollment to delivery, an average of 6 months

  8. Fasting blood sugar

    Blood sugar following a fast

    Measured: From enrollment to delivery, an average of 6 months

  9. Total daily insulin dose

    The total amount of insulin administered to the participant daily

    Measured: From enrollment to delivery, an average of 6 months

  10. Rates of fetal demise

    Whether fetal death occurs prior to delivery

    Measured: From enrollment to delivery, an average of 6 months

  11. Rates of fetal growth restriction among participants

    When the fetus is considered small for gestational age at any point in pregnancy

    Measured: From enrollment to delivery, an average of 6 months

  12. Rates of preeclampsia among participants

    Occurrence of preeclampsia during pregnancy

    Measured: From enrollment to delivery, an average of 6 months

  13. Rates of placental abruption among participants

    Measured: From enrollment to delivery, an average of 6 months

  14. Mode of delivery

    Cesarean or vaginal

    Measured: From enrollment to delivery, an average of 6 months

  15. Number of participants with indication for cesarean delivery

    Measured: From enrollment to delivery, an average of 6 months

  16. Presence of shoulder dystocia

    Vaginal deliveries

    Measured: Duration of delivery, up to 72 hours

  17. Quantitative blood loss

    mL

    Measured: From onset of labor to hospital discharge, up to 42 days post-delivery

  18. Postpartum hemorrhage

    Defined as quantitative blood loss >1000 mL

    Measured: From delivery to hospital discharge, up to 42 days post-delivery

  19. Occurrence of Infection

    Chorioamnionitis or postpartum endometritis prior to discharge

    Measured: From delivery to hospital discharge, up to 42 days

  20. Neonatal birth weight

    Grams

    Measured: From delivery to hospital discharge, up to 42 days

  21. APGAR Scores

    Scored from 0-10, with 10 being the best outcome

    Measured: From delivery to hospital discharge, up to 1 year

  22. Incidence of Neonatal Infection

    Sepsis, fever, positive cultures, or a suspicious clinical course that warrants antibiotics treatment

    Measured: From delivery to hospital discharge, up to 1 year

  23. Rates of respiratory distress syndrome amongst participant infants

    Measured: From delivery to hospital discharge, up to 1 year

  24. Rates of necrotizing enterocolitis amongst participant infants

    Measured: From delivery to hospital discharge, up to 1 year

  25. Rates Neonatal Intensive Care Unit admission amongst participant infants

    Measured: From deliver to NICU admission, up to 1 year

  26. Days in the NICU

    Measured: From NICU admission to NICU discharge, up to 1 year

  27. Hemoglobin A1c

    Blood Hemoglobin A1c level

    Measured: At time of randomization, up to 32 weeks gestation

  28. Hemoglobin A1c

    Blood Hemoglobin A1c levels

    Measured: Between 34 and 36 weeks gestation

  29. C-peptide

    Blood c-peptide levels

    Measured: Collected at time of randomization, up to 32 weeks gestation

  30. C-peptide

    Blood c-peptide levels

    Measured: Between 34 and 36 weeks gestation

  31. Insulin

    Blood insulin levels

    Measured: At time of randomization, up to 32 weeks gestation

  32. Insulin

    Blood insulin level

    Measured: Between 34 and 36 weeks gestation

  33. Leptin

    Blood leptin level

    Measured: At time of randomization, up to 32 weeks gestation

  34. Leptin

    Blood leptin level

    Measured: Between 34 and 36 weeks gestation

  35. Adipoleptin

    Blood adipoleptin

    Measured: At time of randomization, up to 32 weeks gestation

  36. Adipoleptin

    Blood adipoleptin level

    Measured: Between 34 and 36 weeks gestation

  37. Body fat mass

    Mass of body fat determined using bioelectrical impedance analysis

    Measured: At time of randomization, up to 32 weeks gestation

  38. Body fat mass

    Mass of body fat determined using bioelectrical impedance analysis

    Measured: Between 34 and 36 weeks gestation

  39. Body fat percentage

    Body fat percentage determined via bioelectrical impedance analysis

    Measured: At time of randomization, up to 32 weeks gestation

  40. Body fat percentage

    Body fat percentage determined via bioelectrical impedance analysis

    Measured: Between 34 and 36 weeks gestation

  41. Fat free mass

    Measure of body composition, determined by bioelectrical impedance analysis

    Measured: Time of randomization, up to 32 weeks

  42. Fat free mass

    Measure of body composition, determined by bioelectrical impedance analysis

    Measured: Between 34 and 36 weeks gestation

  43. Total body water

    Amount of water in the body, determined by bioelectrical impedance analysis

    Measured: At time of randomization, up to 32 weeks gestation

  44. Total body water

    Amount of water in the body, determined by bioelectrical impedance analysis

    Measured: Between 34 and 36 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07250698
Sponsor's protocol ID
24-06-FB-0155
Status last verified
Nov 2025
First submitted
24 Sep 2025
Last updated
26 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.

    PubMed 25537714

  • Colberg SR, Zarrabi L, Bennington L, Nakave A, Thomas Somma C, Swain DP, Sechrist SR. Postprandial walking is better for lowering the glycemic effect of dinner than pre-dinner exercise in type 2 diabetic individuals. J Am Med Dir Assoc. 2009 Jul;10(6):394-7. doi: 10.1016/j.jamda.2009.03.015. Epub 2009 May 21.

    PubMed 19560716

  • Christie HE, Chang CR, Jardine IR, Francois ME. Three short postmeal walks as an alternate therapy to continuous walking for women with gestational diabetes. Appl Physiol Nutr Metab. 2022 Oct 1;47(10):1031-1037. doi: 10.1139/apnm-2021-0619. Epub 2022 Aug 19.

    PubMed 35985050

  • Andersen MB, Fuglsang J, Ostenfeld EB, Poulsen CW, Daugaard M, Ovesen PG. Postprandial interval walking-effect on blood glucose in pregnant women with gestational diabetes. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100440. doi: 10.1016/j.ajogmf.2021.100440. Epub 2021 Jun 30.

    PubMed 34216833

  • Jovanovic-Peterson L, Durak EP, Peterson CM. Randomized trial of diet versus diet plus cardiovascular conditioning on glucose levels in gestational diabetes. Am J Obstet Gynecol. 1989 Aug;161(2):415-9. doi: 10.1016/0002-9378(89)90534-6.

    PubMed 2764059

  • Garcia-Patterson A, Martin E, Ubeda J, Maria MA, de Leiva A, Corcoy R. Evaluation of light exercise in the treatment of gestational diabetes. Diabetes Care. 2001 Nov;24(11):2006-7. doi: 10.2337/diacare.24.11.2006. No abstract available.

    PubMed 11679479

  • Fishel Bartal M, Ashby Cornthwaite JA, Ghafir D, Ward C, Ortiz G, Louis A, Cornthwaite J, Chauhan SSP, Sibai BM. Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring. Am J Perinatol. 2023 Apr;40(5):461-466. doi: 10.1055/a-1904-9279. Epub 2022 Jul 20.

    PubMed 35858653

  • American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.

    PubMed 30461693

  • Gregory ECW, Ely DM. Trends and Characteristics in Prepregnancy Diabetes: United States, 2016-2021. Natl Vital Stat Rep. 2023 May;72(6):1-13.

    PubMed 37256333

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Pregestational Diabetes and Type 2 Diabetes, run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marwan Ma'ayeh, MD (757-446-7900, MaayehMG@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Glucose Time in Range (time frame: Between 34 and 36 weeks gestation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07250698, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in