Status:
RECRUITING
Thermogenenic Responses to Fasting and Overfeeding in Women
Lead Sponsor:
University of Colorado, Denver
Conditions:
Obesity
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
This study plans to learn more about why menopause increases the risk of weight gain. During and after menopause, women are prone to increased weight gain. The weight gained is primarily body fat, par...
Detailed Description
This cross-sectional study will compare fasting and overfeeding effects on 24-hour EE and its components in pre- and postmenopausal women. The investigators will study participants under three conditi...
Eligibility Criteria
Inclusion
- Inclusion criteria for premenopausal women
- Age 18-45 years.
- Regular menses (no missed cycles in the previous year; cycle length 25-35 d).
- Inclusion criteria for postmenopausal women
- No menses for at least 12 months
- Follicular stimulating hormone (FSH) ≥50 mIU/ml.
- Women who are within 2 years of the final menstrual period are preferred
- The primary exclusion criteria are:
- Body mass index \> 30 kg/m2
- Diabetes (fasting glucose \>126 mg/dL).
- Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \<0.5 or \>5.0 mU/L
- Uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP \>90 mmHg.
- Additional exclusion criteria for postmenopausal women
- History or current use of estrogen-based hormonal therapy
- Women who have undergone surgical menopause.
- Additional exclusion criteria for premenopausal women
- Current hormonal contraceptive use (past 6 mo.).
- Pregnant, lactating, or intention to become pregnant during the study period.
- Participants who fail the thyroid and BP criteria will be considered for enrollment if they receive treatment for these conditions and are considered stable by their treating physician.
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06610162
Start Date
January 1 2025
End Date
December 31 2030
Last Update
April 30 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045