Glucose Control in Type 2 Diabetes in Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Pregestational Diabetes
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwan Ma'ayeh, MD; Phone Number: 757-446-7900; Email: MaayehMG@odu.edu

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Dominion University
      • Contact: Marwan Ma'ayeh, MD; Phone Number: 757-446-7900; Email: MaayehMG@odu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Post-prandial walk; Participants 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.	Behavioral: Exercise; This intervention consists of instructions to walk for 20 minutes after each meal.
No Intervention: Standard of Care; Participants 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between 34 and 36 weeks gestation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postprandial walk	Duration of postprandial walk (in minutes)	From enrollment to delivery, an average of 6 months
Sleep duration	Amount of time spent sleeping	From enrollment to delivery, an average of 6 months
Baseline heart rate	Heart rate when not exercising	From enrollment to delivery, an average of 6 months
Maximal heart rate during walks	Maximal heart rate during postprandial walks	From enrollment to delivery, an average of 6 months
Frequency of aerobic exercise per week	Number of times a participant engages in aerobic exercise each week	From enrollment to delivery, an average of 6 months
Mean glucose level	Average blood sugar level	From enrollment to delivery, an average of 6 months
Blood Glucose Excursions	Changes in blood glucose	From enrollment to delivery, an average of 6 months
Fasting blood sugar	Blood sugar following a fast	From enrollment to delivery, an average of 6 months
Total daily insulin dose	The total amount of insulin administered to the participant daily	From enrollment to delivery, an average of 6 months
Rates of fetal demise	Whether fetal death occurs prior to delivery	From enrollment to delivery, an average of 6 months
Rates of fetal growth restriction among participants	When the fetus is considered small for gestational age at any point in pregnancy	From enrollment to delivery, an average of 6 months
Rates of preeclampsia among participants	Occurrence of preeclampsia during pregnancy	From enrollment to delivery, an average of 6 months
Rates of placental abruption among participants		From enrollment to delivery, an average of 6 months
Mode of delivery	Cesarean or vaginal	From enrollment to delivery, an average of 6 months
Number of participants with indication for cesarean delivery		From enrollment to delivery, an average of 6 months
Presence of shoulder dystocia	Vaginal deliveries	Duration of delivery, up to 72 hours
Quantitative blood loss	mL	From onset of labor to hospital discharge, up to 42 days post-delivery
Postpartum hemorrhage	Defined as quantitative blood loss >1000 mL	From delivery to hospital discharge, up to 42 days post-delivery
Occurrence of Infection	Chorioamnionitis or postpartum endometritis prior to discharge	From delivery to hospital discharge, up to 42 days
Neonatal birth weight	Grams	From delivery to hospital discharge, up to 42 days
APGAR Scores	Scored from 0-10, with 10 being the best outcome	From delivery to hospital discharge, up to 1 year
Incidence of Neonatal Infection	Sepsis, fever, positive cultures, or a suspicious clinical course that warrants antibiotics treatment	From delivery to hospital discharge, up to 1 year
Rates of respiratory distress syndrome amongst participant infants		From delivery to hospital discharge, up to 1 year
Rates of necrotizing enterocolitis amongst participant infants		From delivery to hospital discharge, up to 1 year
Rates Neonatal Intensive Care Unit admission amongst participant infants		From deliver to NICU admission, up to 1 year
Days in the NICU		From NICU admission to NICU discharge, up to 1 year
Hemoglobin A1c	Blood Hemoglobin A1c level	At time of randomization, up to 32 weeks gestation
Hemoglobin A1c	Blood Hemoglobin A1c levels	Between 34 and 36 weeks gestation
C-peptide	Blood c-peptide levels	Collected at time of randomization, up to 32 weeks gestation
C-peptide	Blood c-peptide levels	Between 34 and 36 weeks gestation
Insulin	Blood insulin levels	At time of randomization, up to 32 weeks gestation
Insulin	Blood insulin level	Between 34 and 36 weeks gestation
Leptin	Blood leptin level	At time of randomization, up to 32 weeks gestation
Leptin	Blood leptin level	Between 34 and 36 weeks gestation
Adipoleptin	Blood adipoleptin	At time of randomization, up to 32 weeks gestation
Adipoleptin	Blood adipoleptin level	Between 34 and 36 weeks gestation
Body fat mass	Mass of body fat determined using bioelectrical impedance analysis	At time of randomization, up to 32 weeks gestation
Body fat mass	Mass of body fat determined using bioelectrical impedance analysis	Between 34 and 36 weeks gestation
Body fat percentage	Body fat percentage determined via bioelectrical impedance analysis	At time of randomization, up to 32 weeks gestation
Body fat percentage	Body fat percentage determined via bioelectrical impedance analysis	Between 34 and 36 weeks gestation
Fat free mass	Measure of body composition, determined by bioelectrical impedance analysis	Time of randomization, up to 32 weeks
Fat free mass	Measure of body composition, determined by bioelectrical impedance analysis	Between 34 and 36 weeks gestation
Total body water	Amount of water in the body, determined by bioelectrical impedance analysis	At time of randomization, up to 32 weeks gestation
Total body water	Amount of water in the body, determined by bioelectrical impedance analysis	Between 34 and 36 weeks gestation

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: exercise; continuous glucose monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 24-06-FB-0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No