Glucose Control in Type 2 Diabetes in Pregnancy

Официальное название

Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Blood Glucose Time in Range [Срок оценки: Between 34 and 36 weeks gestation.]

Вторичные конечные точки (12)

• Duration of postprandial walk [Срок оценки: From enrollment to delivery, an average of 6 months]
• Sleep duration [Срок оценки: From enrollment to delivery, an average of 6 months]
• Baseline heart rate [Срок оценки: From enrollment to delivery, an average of 6 months]
• Maximal heart rate during walks [Срок оценки: From enrollment to delivery, an average of 6 months]
• Frequency of aerobic exercise per week [Срок оценки: From enrollment to delivery, an average of 6 months]
• Mean glucose level [Срок оценки: From enrollment to delivery, an average of 6 months]
• Blood Glucose Excursions [Срок оценки: From enrollment to delivery, an average of 6 months]
• Fasting blood sugar [Срок оценки: From enrollment to delivery, an average of 6 months]
• Total daily insulin dose [Срок оценки: From enrollment to delivery, an average of 6 months]
• Rates of fetal demise [Срок оценки: From enrollment to delivery, an average of 6 months]
• Rates of fetal growth restriction among participants [Срок оценки: From enrollment to delivery, an average of 6 months]
• Rates of preeclampsia among participants [Срок оценки: From enrollment to delivery, an average of 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Domi — Norfolk

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07250698 · 24-06-FB-0155

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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