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Effects of High Altitude on AMPK Activation

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ClinicalTrials.gov Identifier: NCT02391519
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy IUGR Preeclampsia Procedure: Collection of myometrial, cord blood, and placental tissue samples

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of High Altitude on 5' Adenosine Monophosphate-activated Protein Kinase (AMPK) Activation and Peroxisome Proliferator-activated Receptor Gamma (PPARγ) Regulation
Study Start Date : January 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High Altitude (3000 m)
Collection of 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).
Procedure: Collection of myometrial, cord blood, and placental tissue samples
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).

Low Altitude (1600 m)
Collection of 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).
Procedure: Collection of myometrial, cord blood, and placental tissue samples
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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Myometrial tissue, Cord Blood, Placental Tissue.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m) will be identified. In order to avoid any possible confounding effects of labor or prematurity, only women with elective cesarean deliveries will be approached for enrollment (cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391519


Contacts
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Contact: Lorna Moore, PhD 303-724-7474 lorna.moore@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Lorna Moore, PhD         
Sub-Investigator: Anna Euser, MD         
Sub-Investigator: Colleen Julian, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Lorna Moore, PhD University of Colorado, Denver

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02391519     History of Changes
Other Study ID Numbers: 14-2178
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by University of Colorado, Denver:
Pregnancy
High altitude
vasoreactivity
myometrial arteries
Additional relevant MeSH terms:
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Altitude Sickness
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Respiration Disorders
Respiratory Tract Diseases