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Gestational Diabetes MellitusFITT-BNCT07802262

Prenatal Exercise and Glucose Regulation

A study testing Acute exercises sessions with different exercise types and intensities in people with Gestational Diabetes Mellitus and Gestational Diabetes Mellitus in Pregnancy, run by University of Central Arkansas at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
Acute exercises sessions with different exercise types and intensities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to 31 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brittany R Tucker, PhD contact

484-802-6852

rallman@uca.edu

Jamie Baum, PhD contact

479-601-2499

baum@uark.edu

United States1 site, 1 recruiting
  • Human Performance Laboratory (HPL) at the University of Central Arkansas

    Conway, Arkansas, 72035

    Brittany R Tucker, PhD, 484-802-6852, rallman@uca.edu

    Michael Gallagher, PhD, 501-450-5706, gallagherm@uca.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Acute exercises sessions with different exercise types and intensities
Keywords
exercise, resistance training, cardiorespiratory training, insulin resistance, glucose regulation, glucose, insulin, insulin sensitivity, QUICKI, weightlifting, aerobic training, prenatal, pregnancy, exercise intensity, exercise type
Medical subject headings
Diabetes, Gestational, Insulin Resistance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute exercises sessions with different exercise types and intensitiesBehavioural

    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.

Study groups in NCT07802262
Study groupRoleWhat they receive
Women with Gestational Diabetes MellitusOtherTwenty-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.
Receives: Behavioral: Acute exercises sessions with different exercise types and intensities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour glucose regulation

    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).

    Measured: 24 hours

Secondary outcomes (1)
  1. Insulin sensitivity

    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.

    Measured: Acute (~1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start24 Sep 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07802262
Sponsor's protocol ID
23-201
Acronym
FITT-B
Status last verified
Jul 2026
First submitted
15 May 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acute exercises sessions with different exercise types and intensities in people with Gestational Diabetes Mellitus and Gestational Diabetes Mellitus in Pregnancy, run by University of Central Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brittany R Tucker, PhD (484-802-6852, rallman@uca.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour glucose regulation (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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