Glucose Control in Type 2 Diabetes in Pregnancy

NCT ID: NCT07250698

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregestational Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eastern Virginia Medical School

OTHER

Sponsor Role lead

Responsible Party

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Marwan Ma'ayeh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Norfolk, Virginia, United States

Site Status

Countries

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United States

Central Contacts

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Marwan Ma'ayeh, MD

Role: CONTACT

757-446-7900

Facility Contacts

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Marwan Ma'ayeh, MD

Role: primary

757-446-7900

References

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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.

Reference Type BACKGROUND
PMID: 25537714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19560716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35985050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34216833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2764059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11679479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35858653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30461693 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 37256333 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Experimental Consent Form

View Document

Document Type: Informed Consent Form: Control Consent Form

View Document

Other Identifiers

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24-06-FB-0155

Identifier Type: -

Identifier Source: org_study_id

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