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| ID | Type | Description | Link |
|---|---|---|---|
| P50HD073063 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Menopause is associated with weight gain, but the reasons why are not clear. In this study, the investigators will determine if reducing estrogen levels causes a decrease in the ability of the body to produce heat. If so, this would suggest this is one way that menopause may cause weight gain.
The purpose of this pilot study is to investigate the role of the female sex hormone estrogen, on metabolism, thermoregulation and energy expenditure. Weight and fat gain increase after the menopause, but reasons for this are not clear. Loss of estrogen may cause changes in how women regulate metabolism and thermoregulation, possibly leading to weight gain. Specifically, this study will determine how loss of estrogen affects facultative thermogenesis. Loosely defined, facultative thermogenesis represents heat production that is turned on when needed. For example, when body core temperature falls below a certain threshold, a shivering response is invoked in skeletal muscle to increase heat production and, thus, energy expenditure. However, exposure over several hours to mild cold temperatures that do not trigger shivering (16-20⁰ C) also induces an increase in energy expenditure (cold-induced non-shivering thermogenesis). Although several different tissues may contribute to this response, the recent identification of functional brown adipose tissue (BAT) in humans has promoted an interest in how BAT is activated in humans and its potential role in regulating energy balance and body weight. The investigators will measure BAT activity using PET/CT scans pre and post three months of estrogen suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estrogen suppression | Experimental | Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estrogen suppression | Drug | Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brown Adipose Tissue Activity | Brown adipose tissue activity will be measured using Positron Emission Tomography/computer tomography (PET/CT) before and after 3 months of estrogen suppression. Activity is quantified as the standard uptake value (SUV), It is a mathematically derived ratio that is a semiquantitative measure of the tracer uptake in a region of interest that normalizes the lesion activity to the injected activity and a measure of the volume of distribution (usually total body weight or lean body mass). | Baseline and after 3 months of suppression |
| Measure | Description | Time Frame |
|---|---|---|
| Cold Induced Thermogenesis | The increase in energy expenditure above resting during cold exposure | Baseline and after 3 months of suppression |
| Fat Mass | Amount of body fat (in kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Melanson, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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Participants were recruited through advertisements posted on the Anschutz Medical Campus and distributed through the campus email system. 12 women consented to participate in the study (consent was obtained prior to screening and orientation). After the screening and orientation process, 6 elected to continue, and 6 elected not to continue
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| ID | Title | Description |
|---|---|---|
| FG000 | Estrogen Suppression | Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones Estrogen suppression: Participants underwent 3 mo of ovarian hormone suppression using the GnRHAG leuprolide acetate (Lupron; TAP Pharmaceutical Products, Inc; Lake Forest, IL) delivered by monthly intramuscular injection (3.75 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Estrogen Suppression | Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones Estrogen suppression: Participants underwent 3 mo of ovarian hormone suppression using the GnRHAG leuprolide acetate (Lupron; TAP Pharmaceutical Products, Inc; Lake Forest, IL) delivered by monthly intramuscular injection (3.75 mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brown Adipose Tissue Activity | Brown adipose tissue activity will be measured using Positron Emission Tomography/computer tomography (PET/CT) before and after 3 months of estrogen suppression. Activity is quantified as the standard uptake value (SUV), It is a mathematically derived ratio that is a semiquantitative measure of the tracer uptake in a region of interest that normalizes the lesion activity to the injected activity and a measure of the volume of distribution (usually total body weight or lean body mass). | Posted | Mean | Standard Deviation | Standard uptake value (SUV) | Baseline and after 3 months of suppression |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Estrogen Suppression | Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones Estrogen suppression: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
This was a pilot study to generate preliminary data for an NIH grant application. there was insufficient power to detect significant differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Melanson, PhD | University of Colorado Anschutz Medical Campus | 303-724-0935 | ed.melanson@cuanschutz.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| Baseline and after 3 months of suppression |
| Fat Free Mass | Fat free mass measured by DXA | Baseline and after 3 mo of suppression |
| Resting Energy Expenditure | Energy expenditure measured in the resting state | after 3 months of suppression |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | kg |
|
| Fat mass (measured with DXA) | Mean | Standard Deviation | kg |
|
| fat free mass (from DXA) | Mean | Standard Deviation | kg |
|
|
|
|
| Secondary | Cold Induced Thermogenesis | The increase in energy expenditure above resting during cold exposure | Posted | Mean | Standard Deviation | kcal | Baseline and after 3 months of suppression |
|
|
|
|
| Secondary | Fat Mass | Amount of body fat (in kg) | Posted | Mean | Standard Deviation | kg | Baseline and after 3 months of suppression |
|
|
|
|
| Secondary | Fat Free Mass | Fat free mass measured by DXA | Posted | Mean | Standard Deviation | kg | Baseline and after 3 mo of suppression |
|
|
|
|
| Secondary | Resting Energy Expenditure | Energy expenditure measured in the resting state | Posted | Mean | Standard Deviation | kcal | after 3 months of suppression |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| Headaches | General disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |