No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Female
Study type
Interventional
Purpose
Basic Science
Participants needed
56 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for women to understand how menopause affects weight gain. Participants will fast for 24 hours and then eat extra calories to see how their bodies respond.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18-45 years and have regular menstrual cycles.
I have not had a period for at least 12 months and have a FSH level of 50 or higher.
You may not be able to join if
I have a body mass index over 30.
I have diabetes.
I have thyroid problems.
I have uncontrolled high blood pressure.
I use estrogen-based hormonal therapy or have had surgical menopause.
I use hormonal contraceptives or am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, particularly visceral or abdominal body fat. The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes. The increase in weight …
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, particularly visceral or abdominal body fat. The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes. The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen. This study plans to compare how the metabolism of premenopausal and postmenopausal women responds to changes in energy intake. The investigators will compare the changes in energy expenditure that occur during a period of acute fasting (24 hours) and a period of consuming excess calories (overfeeding).
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Eligibility Criteria
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 …
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.
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