Last reviewed · How we verify
NCT03838146
Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics
NA trial testing Types of Exercise in Exercise in 167 participants. Completed in 30 January 2023.
30 January 2023
Quick facts
| Lead sponsor | East Carolina University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 167 |
| Start date | 1 September 2018 |
| Primary completion | 30 January 2023 |
| Estimated completion | 30 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Types of Exercise
Conditions studied
- Exercise — all drugs for Exercise →
Sponsor
East Carolina University
Who can join
Adults 18 to 35, female only, with Exercise. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.\[1, 2\] Insulin resistance in skeletal muscle is believed to be a critical contributor to the metabolic syndrome which increases the risk for cardiovascular disease (CVD). Conversely, exercise improves insulin sensitivity and many other facets of skeletal muscle function and metabolism; however, it is unclear if this positive effect can be "imprinted" in the skeletal muscle of the fetus with maternal exercise and accordingly diminish CVD risk in offspring. Our previous studies found that exercise during pregnancy leads to improved heart measures and reduced adiposity.\[3-6\] These studies demonstrated the potential for maternal exercise to reduce risk for CVD, but the cellular mechanisms involved, however, are not clearly evident. The proposed project will fill this critical gap and assess the influence of maternal exercise intervention to "imprint" progenitor stem cells in the fetus (umbilical cord tissue) to develop into insulin sensitive skeletal muscle and also improve indices of infant morphometry and movement. Using a randomized design, 160 women will perform either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk. The investigators will test the central hypothesis that exercise during pregnancy alters skeletal muscle in a manner which decreases the risk of heart disease in offspring. To test this central hypothesis, the investigators will pursue two specific aims: Aim 1- Determine the ability of regular maternal exercise to imprint key myocellular metabolic (insulin sensitivity) properties of offspring mesenchymal stem cells (MSC), neuromotor function, and morphometry. Aim 2- Determine the distinct abilities of regular maternal exercise to imprint the metabolome of offspring MSC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effects of Maternal Exercise Modes on Glucose and Lipid Metabolism in Offspring Stem Cells.
Jevtovic F, Zheng D, Houmard JA, Krassovskaia PM, et al · · 2023 · cited 29× · PMID 36722208 · DOI 10.1210/clinem/dgad059 -
Effects of maternal exercise on infant mesenchymal stem cell mitochondrial function, insulin action, and body composition in infancy.
Jevtovic F, Zheng D, Claiborne A, Biagioni EM, et al · · 2024 · cited 16× · PMID 38684442 · DOI 10.14814/phy2.16028 -
Influence of prenatal exercise on the relationship between maternal overweight and obesity and select delivery outcomes.
McDonald SM, Mouro S, Wisseman B, Isler C, et al · · 2022 · cited 11× · PMID 36243785 · DOI 10.1038/s41598-022-22283-0 -
Maternal exercise increases infant resting energy expenditure: preliminary results.
Jevtovic F, Collier DN, DeVente J, Mouro S, et al · · 2024 · cited 10× · PMID 38858465 · DOI 10.1038/s41366-024-01560-0 -
Exercise FITT-V during pregnancy: Association with birth outcomes.
Claiborne A, Wisseman B, Kern K, Steen D, et al · · 2024 · cited 8× · PMID 38659157 · DOI 10.1002/bdr2.2340 -
Paternal obesity decreases infant MSC mitochondrial functional capacity.
Jevtovic F, Claiborne A, Biagioni EM, Collier DN, et al · · 2024 · cited 6× · PMID 39140975 · DOI 10.1152/ajpendo.00239.2024 -
Exercise during pregnancy Dose: Influence on preterm birth outcomes.
Claiborne A, Wisseman B, Kern K, Steen D, et al · · 2024 · cited 6× · PMID 39025039 · DOI 10.1016/j.ejogrb.2024.07.017 -
Exercise during pregnancy modulates infant cellular and whole-body adiposity.
Claiborne A, Jevtovic F, Zheng D, Strom C, et al · · 2024 · cited 3× · PMID 39617638 · DOI 10.14814/phy2.70145
Verify or expand the search:
- PubMed search for NCT03838146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Exercise
Currently open trials in the same condition.
- NCT07504068 — Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in · NA · recruiting
- NCT07479940 — Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters · NA · active not recruiting
- NCT07498530 — Virtual Assistant for Exercise Adherence in Older ADULTS · NA · recruiting
- NCT07426172 — Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism. · NA · recruiting
- NCT07276477 — Inspiratory Muscle Training After Stroke · NA · recruiting
Other East Carolina University trials
Trials by the same sponsor.
- NCT07390760 — Remote Ischemic Conditioning and Spinal Reflex Modulation in Children With Cerebral Palsy · NA · recruiting
- NCT07525193 — PREnatal Choline and Infant Outcomes Study · NA · recruiting
- NCT06860464 — Remote Ischemic Conditioning and Spinal Reflex Modulation · NA · enrolling by invitation
- NCT06420193 — Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit · NA · completed
- NCT06319014 — Physical Activity to Mitigate PreEclampsia Risk · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03838146 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by East Carolina University
- Last refreshed: 8 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03838146.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing