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NCT Number: NCT02391519

Effects of High Altitude on AMPK Activation

Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high altitude and may contribute to the observed 3-fold increase in intrauterine growth restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Anna Euser, MD

SUB_INVESTIGATOR

Colleen Julian, PhD

SUB_INVESTIGATOR

Lorna Moore, PhD

PRINCIPAL_INVESTIGATOR

About this study

The Investigators will determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries. This will be novel information regarding pregnancy at altitude and of significance not just for women and families in Colorado, but also at high-altitude locations throughout the world. If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.

The Investigators will also determine whether the chronic hypoxia of high altitude alters DNA methylation patterns and expression of key genes involved in metabolic homeostasis in maternal, placental and fetal cells and, in turn, the relationship of these changes to fetal growth and maternal well-being.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m)
  • Cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation

Exclusion criteria

  • Women will be excluded if there are co-existing medical diagnoses that are known to affect vascular parameters (i.e., diabetes mellitus, gestational diabetes, any hypertensive disorder of pregnancy, or a current smoker).
  • Women with multiple gestations and preterm deliveries will also be excluded.

Treatment and study plan

Collection of myometrial, cord blood, and placental tissue samples

Procedure

We propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA).

Primary outcomes

  1. Changes in Myometrial artery dimensions

    Time frame: Up to 1 year

    Myometrial artery dimensions as quantified by immunohistochemistry or other staining techniques, and results of studies of isolated myometrial artery studies in which vasoconstrictor and vasodilator responses to pharmacological agonists are measured using absolute values and the percent maximal contraction to potassium chloride.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorna Moore, PhD

CONTACT

[email protected]

303-724-7474

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Effects of High Altitude on 5' Adenosine Monophosphate-activated Protein Kinase (AMPK) Activation and Peroxisome Proliferator-activated Receptor Gamma (PPARγ) Regulation

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2015
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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