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NCT03838146 · ClinicalTrials.gov registry record · NA

Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics

A NA study, sponsored by East Carolina University.

Completed
Registry status
NA
Development phase
167
Enrollment target

NCT03838146: Completed NA study, sponsored by East Carolina University.

NCT03838146 is a NA study that has completed, run by East Carolina University. The registered enrollment target is 167 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03838146, a NA study, has completed, sponsored by East Carolina University.

COMPLETED
Registry status
NA
Development phase
167 participants
Enrollment target

Study Summary

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 skele

Primary Outcome

Western blot analysis of Akt phosphorylation will be conducted on cell lysates from myotubes under basal or following insulin-stimulation. Glycogen synthesis will be measured under basal and insulin-stimulated conditions. Data will be presented as % change in glycogen synthesis following insulin stimulation.

Interventions

  • BEHAVIORAL Types of Exercise

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2018-09-01
Est. Completion 2023-01-30
Phase NA
East Carolina University

58 total trials

What the finished NCT03838146 record still lists

NCT03838146 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which Types of Exercise is the first listed.

NCT03838146 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03838146 about?

NCT03838146 is a clinical study titled "Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics". 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 b...

What is the current status of trial NCT03838146?

This trial is currently completed. It is a NA study. The enrollment target is 167 participants. The study started on 2018-09-01. Estimated completion is 2023-01-30.

What interventions are being tested in trial NCT03838146?

The interventions under investigation include: Types of Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT03838146?

This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03838146's enrollment target sits among peer trials

167 622nd of 2000 higher than 1,376 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03838146, the US trial registry maintained by the National Library of Medicine. NCT03838146 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.