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RecruitingNCT07802262FITT-BUpdated Sep 3, 2026

Prenatal Exercise and Glucose Regulation

An interventional study of Acute exercises sessions with different exercise types and intensities in Gestational Diabetes Mellitus, Gestational Diabetes Mellitus in Pregnancy and Insulin Resistance, sponsored by University of Central Arkansas. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by University of Central Arkansas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Gestational Diabetes Mellitus
  • Gestational Diabetes Mellitus in Pregnancy
  • Insulin Resistance

Keywords

  • exercise
  • resistance training
  • cardiorespiratory training
  • insulin resistance
  • glucose regulation
  • glucose
  • insulin
  • insulin sensitivity
  • QUICKI
  • weightlifting
  • aerobic training
  • prenatal
  • pregnancy
  • exercise intensity
  • exercise type
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (estimated)

Study arms

  • Other
    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.

    Behavioral: Acute exercises sessions with different exercise types and intensities

Interventions

  • BehavioralAcute exercises sessions with different exercise types and intensities

    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.

05

What researchers measure

Primary outcomes

  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).

    Time frame: 24 hours

Secondary outcomes

  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.

    Time frame: Acute (~1 hour)

06

Study locations

1 of 1 sites recruiting
  • Human Performance Laboratory (HPL) at the University of Central Arkansas
    Conway, Arkansas 72035, United States
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 19, 2024
  • Informed consent form · Sep 19, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07802262
Lead sponsor
University of Central Arkansas
Responsible party
Brittany Tucker (Assistant Professor, University of Central Arkansas) — Principal investigator
First posted
Sep 3, 2026
Start date
Sep 24, 2024
Primary completion
Aug 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

Brittany R Tucker, PhD
Contact
rallman@uca.edu
484-802-6852
Jamie Baum, PhD
Contact
baum@uark.edu
479-601-2499
Brittany R Tucker, PhD
principal investigator · University of Central Arkansas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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