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
Among 251 studies in Diabetes, Gestational with a site in United States — 53 open to participants now, 65 under way, 2 of them phase 3. Diabetes, Gestational · United States.
Among the 251 studies in Diabetes, Gestational with a site in United States, this one is the 153rd largest by planned enrollment of the 194 interventional ones, is one of 16 that started in 2024, is one of 154 with no phase, reaches primary completion later than 47 of the 64 other live ones, and was the 211th registered.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 23 is below the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →53 of the 251 studies in Diabetes, Gestational with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.
This study: 18 Years to 35 Years · female · healthy volunteers too.
The full table on the hub →251 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 16 started in 2024.
Median enrollment 80 across the 194 interventional studies, 72 across the 57 observational. Of the 154 that completed or were terminated, 35 (23%) have results posted.
10 of 251 have an industry lead sponsor. The 10 most frequent:
University of Central Arkansas is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
University of Central Arkansas has 1 study filed under Diabetes, Gestational — fewer than ten, so there is no comparison to draw.
22 of the studies in Diabetes, Gestational with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07356180University of Maryland, BaltimorePhysical Acvitiy in Pregnancy | 2026-12 |
| NCT05909046Ohio State UniversityA Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE | 2026-12 |
| NCT05388643University of Massachusetts, WorcesterEarly Detection of Gestational Diabetes Mellitus in Pregnancy | 2026-12-01 |
| NCT07176793University of California, DavisPregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes | 2026-12-30 |
| NCT05124808Indiana UniversityIntensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes | 2026-12-31 |
Among the 251 studies in Diabetes, Gestational with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Aug 2027, 35 months after the start.
Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 35 months is above that.
Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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University of Central Arkansas