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Prenatal Exercise and Glucose Regulation (FITT-B)

31 августа 2026 г. обновлено: Brittany Tucker, University of Central Arkansas

The Impact of Prenatal Exercise Type and Intensity on Glucose Control in Pregnant Women

Gestational diabetes mellitus (GDM) is the most common disease during pregnancy and is characterized by an inability to regulate blood glucose (sugar) levels because of resistance to the hormone, insulin, which is responsible for getting glucose out of the blood. Aerobic training (AT, "cardio," for example: walking) is commonly used to regulate blood glucose levels in similar populations, like diabetics, but another form of exercise known as resistance training (RT, for example: weightlifting), has shown to be just as effective. Further, exercise intensity, regardless of the type, is directly proportional to blood glucose control. However, no study has compared AT and RT exercise modalities or intensity on blood glucose regulation in GDM, even though women with GDM share a similar insulin resistant phenotype as diabetics. Therefore, long-term objective of this study is to compare the effects of exercise type and intensity on glucose regulation and insulin sensitivity after four acute exercise sessions: low intensity RT (LOW-RT), low intensity AT (LOW-AT), moderate intensity RT (MOD-RT), moderate intensity AT (MOD-AT). Researchers will address the following aims:

Specific Aim 1: Determine the impact of exercise type and intensity on glucose regulation using continuous glucose monitoring during- and for 24 hours after four acute exercise sessions: LOW-RT, LOW-AT, MODRT, and MOD-AT. Researchers hypothesize that RT and moderate intensity will elicit better glucose control compared to AT and low intensity, respectively.

Specific Aim 2: Determine the impact of exercise type and intensity on insulin sensitivity by quantifying the quantitative insulin-sensitivity check index (QUICKI) before and after four acute exercise sessions: LOWRT, LOW-AT, MOD-RT, and MOD-AT. Researchers hypothesize that RT and moderate intensity will elicit greater insulin sensitivity compared to AT and low intensity, respectively.

Обзор исследования

Подробное описание

Gestational diabetes mellitus (GDM) is defined as an inability to manage blood glucose (sugar) levels that is first diagnosed during pregnancy and poses a significant threat to the mom and baby. Even so, current pharmacological treatment strategies may not affect the root cause of the problem (reduced sensitivity to insulin) in the same way that other adjuvant therapies, like exercise, do. In fact, exercise has been coined as "medicine" in many professional organizations because of its regenerative nature, owing to its ability to improve physiological outcomes just like pharmacological treatments.

As such, exercise prescription, like drug prescription, must be specific and consider several key variables, such as those described in the FITT principle for exercise: frequency (how often), intensity (how hard), time (how many minutes), and type (which kind of exercise). Although resistance training (RT, a type of exercise) and higher intensities of exercise are tremendously influential on insulin sensitivity and consequent glucose regulation in populations with similar physiological burdens as GDM (e.g., type 2 diabetes mellitus), no study to date has thoroughly explored the impact of these variables in GDM. Furthermore, in general, prenatal exercise recommendations prescribing FITT are for the very general health of the mom and baby. However, "general health" tends to be quite myopic for a population such as GDM, whose characteristic physiological issue is insulin insensitivity, which thus should be the main target. Therefore, a major obstacle in the field of prenatal exercise is determining what FITT exercise prescription is optimal for insulin sensitivity and glucose regulation in GDM, and not simply overall health (again, much like medicine). In effect, my long-term goal is to determine the appropriate FITT prescription for optimal insulin sensitivity and glucose regulation in GDM. My central hypothesis is that the current FITT prescription for prenatal exercise in GDM grossly underestimates what is needed for optimal insulin sensitivity and glucose regulation. To begin testing my hypothesis, in the proposed study, I will seek to address two aims:

Specific Aim 1: Determine the impact of exercise type (resistance training [RT], aerobic training [AT]) and intensity (low, moderate) on glucose regulation in GDM by assessing real-time blood glucose levels using continuous glucose monitoring (CGM) during and for 24 hours after an acute bout of exercise in four conditions: low intensity RT (LOW-RT), low intensity AT (LOW-AT), moderate intensity RT (MOD-RT), and moderate intensity AT (MOD-AT). The hypothesis is that MOD-RT will elicit the most optimal glucose regulation throughout the 24-hour window, followed by MOD-AT, then LOW-RT, and finally LOW-AT.

Specific Aim 2: Determine the impact of exercise type (RT, AT) and intensity (low, moderate) on insulin sensitivity in GDM by calculating the quantitative insulin-sensitivity check index (QUICKI) using blood glucose levels before and after an acute bout of exercise in four conditions: LOW-RT, LOW-AT, MOD-RT, and MODAT. The hypothesis is that MOD-RT will elicit the greatest change in insulin sensitivity, followed by MOD-AT, then LOW-RT, and finally LOW-AT.

This data could be immensely informative for prescribing exercise for optimal metabolic health in GDM and could therefore be used to manage acute changes in glucose levels in this population. For example, if the hypothesis of this study is confirmed, this may mean that if a woman with GDM has a brief episode of high glucose levels (e.g., after a high-sugar meal), she may be "prescribed" a form of RT at a certain intensity to get her glucose levels back to baseline, instead of-/in concert with- pharmacological approaches, therefore, effectively using specific exercise prescription as a form of medicine. In the future, I plan to determine the optimal prescription of the other FITT variables (frequency and time) for optimizing glucose regulation in GDM. Then I will use this exercise prescription in a long-term exercise training study in GDM and examine the impacts on both the mom and baby.

Тип исследования

Интервенционный

Регистрация (Оцененный)

23

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Brittany R Tucker, PhD
  • Номер телефона: 484-802-6852
  • Электронная почта: rallman@uca.edu

Учебное резервное копирование контактов

  • Имя: Jamie Baum, PhD
  • Номер телефона: 479-601-2499
  • Электронная почта: baum@uark.edu

Места учебы

    • Arkansas
      • Conway, Arkansas, Соединенные Штаты, 72035
        • Рекрутинг
        • Human Performance Laboratory (HPL) at the University of Central Arkansas
        • Контакт:
          • Brittany R Tucker, PhD
          • Номер телефона: 484-802-6852
          • Электронная почта: rallman@uca.edu
        • Контакт:
          • Michael Gallagher, PhD
          • Номер телефона: 501-450-5706
          • Электронная почта: gallagherm@uca.edu

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion Criteria:

  • Biological female
  • Singleton (one fetus)
  • 24-30-wks gestation
  • 18-35 yrs old
  • Sedentary
  • Conception without the use of assisted fertility treatments

Exclusion Criteria:

  • Existing other metabolic disorders
  • Currently taking medication or supplements that affect glucose metabolism
  • Taking drugs, tobacco, or alcohol during pregnancy
  • Having a contraindication to exercise

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: Women with Gestational Diabetes Mellitus
Twenty-three women in the second to third trimester of pregnancy will be recruited for this study. Inclusion criteria will consist of: biological female, singleton (one fetus), 24-30-wks gestation, 18-35 yrs old, sedentary, and conception without the use of assisted fertility treatments. Exclusion criteria will consist of existing other metabolic disorders, currently taking medication or supplements that affect glucose metabolism, taking drugs, tobacco, or alcohol during pregnancy, having a contraindication to exercise.
During both RT sessions, participants will perform eight exercises that will target the whole body. Exercises will be performed using dumbbells at four sets of 10 repetitions, with one minute of rest between sets. The first set will be done with very light weight (warm-up). The next three sets will be the "working sets," done with a weight that will elicit the proper intensity. During AT, participants will use either a treadmill, bike, elliptical, or rower. Throughout the 45-minute session, every five minutes, the participant will report their RPE, and if they report low, speed will be increased by 0.1-0.5 mph until the proper intensity is achieved. Incline/resistance will not be used to modulate intensity, to ensure that there are no mechanical influences on AT that mimic the nature of RT.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
24-hour glucose regulation
Временное ограничение: 24 hours
Determine the impact of exercise type (resistance training [RT], aerobic training [AT]) and intensity (low, moderate) on glucose regulation in GDM by assessing real-time blood glucose levels using continuous glucose monitoring (CGM) during and for 24 hours after an acute bout of exercise in four conditions: low intensity RT (LOW-RT), low intensity AT (LOW-AT), moderate intensity RT (MOD-RT), and moderate intensity AT (MOD-AT).
24 hours

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Insulin sensitivity
Временное ограничение: Acute (~1 hour)
Determine the impact of exercise type (RT, AT) and intensity (low, moderate) on insulin sensitivity by calculating the quantitative insulin-sensitivity check index (QUICKI) using blood glucose levels before and after an acute bout of exercise in four conditions: LOW-RT, LOW-AT, MOD-RT, and MODAT.
Acute (~1 hour)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Brittany R Tucker, PhD, University of Central Arkansas

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

24 сентября 2024 г.

Первичное завершение (Оцененный)

31 августа 2027 г.

Завершение исследования (Оцененный)

31 января 2028 г.

Даты регистрации исследования

Первый отправленный

15 мая 2024 г.

Впервые представлено, что соответствует критериям контроля качества

31 августа 2026 г.

Первый опубликованный (Действительный)

3 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

31 августа 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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