Glucose Control in Type 2 Diabetes in Pregnancy

NCT07250698 | Not Yet Recruiting

• 1 other identifier: 24-06-FB-0155
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 will compare the glucose control of two groups: one that walks for 20 minutes after each meal, and one that does not.

Conditions

Pregestational Diabetes; Type 2 Diabetes

Keywords

exercise; continuous glucose monitoring

Outcome Measures

Primary Outcomes (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.

  Between 34 and 36 weeks gestation.

Secondary Outcomes (44)

• Duration of postprandial walk

  From enrollment to delivery, an average of 6 months

• Sleep duration

  From enrollment to delivery, an average of 6 months

• Baseline heart rate

  From enrollment to delivery, an average of 6 months

• Maximal heart rate during walks

  From enrollment to delivery, an average of 6 months

• Frequency of aerobic exercise per week

  From enrollment to delivery, an average of 6 months

Study Arms (2)

Post-prandial walk

ACTIVE COMPARATOR

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

Standard of Care

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

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

Post-prandial walk

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

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

Norfolk, Virginia, 23507, United States

Location

Related Publications (9)

• 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.

  PMID: 25537714 BACKGROUND

• 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.

  PMID: 19560716 BACKGROUND

• 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.

  PMID: 35985050 BACKGROUND

• 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.

  PMID: 34216833 BACKGROUND

• 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.

  PMID: 2764059 BACKGROUND

• 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.

  PMID: 11679479 BACKGROUND

• 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.

  PMID: 35858653 BACKGROUND

• 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.

  PMID: 30461693 BACKGROUND

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

  PMID: 37256333 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marwan Ma'ayeh, MD

CONTACT

757-446-7900; MaayehMG@odu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)