Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2025-04-21
2028-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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Active
Exercise \> 3 days per week of moderate-intensity exercise
Pre-Pregnancy BMI
Pre-pregnancy BMI between 18.5-24.99
Pre-Pregnancy BMI
Pre-pregnancy BMI between 25-39.99
Inactive
≤ 1 day per week of exercise
Pre-Pregnancy BMI
Pre-pregnancy BMI between 18.5-24.99
Pre-Pregnancy BMI
Pre-pregnancy BMI between 25-39.99
Interventions
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Pre-Pregnancy BMI
Pre-pregnancy BMI between 18.5-24.99
Pre-Pregnancy BMI
Pre-pregnancy BMI between 25-39.99
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Participation in a structured exercise program ≥ 1 day/week in the "inactive" subcohort or \< 3 days per week in the "active" subcohort.
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
* Abnormal liver function test results (Transaminase \>2 times the upper limit of normal
* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2);
* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
* Abuse of alcohol or recreational drugs
* Active tobacco smoking within the past 3 months
* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening.
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Active pregnancy
* Restrictions on Use of Other Drugs or Treatments:
* Any other medication believed to be a contraindication to the subject's participation.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mark Pataky
Principal Investigator
Principal Investigators
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Mark Pataky, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-006207
Identifier Type: -
Identifier Source: org_study_id
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