Trial Outcomes & Findings for Effects of Estrogen Deficiency on Energy Expenditure (NCT NCT01846728)

Last Updated: 2019-11-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline and after 3 months of suppression

Results posted on

2019-11-18

Participant Flow

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

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Estrogen Deficiency on Energy Expenditure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estrogen Suppression n=6 Participants 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).
Age, Continuous	31 years STANDARD_DEVIATION 6 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Body mass index	24.3 kg/m^2 STANDARD_DEVIATION 4.5 • n=93 Participants
Weight	64.8 kg STANDARD_DEVIATION 16.3 • n=93 Participants
Fat mass (measured with DXA)	24.2 kg STANDARD_DEVIATION 8.9 • n=93 Participants
fat free mass (from DXA)	40.3 kg STANDARD_DEVIATION 8.4 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline and after 3 months of suppression

Outcome measures

Outcome measures
Measure	Estrogen Suppression n=6 Participants 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
Brown Adipose Tissue Activity Baseline	3.9 Standard uptake value (SUV) Standard Deviation 1.8
Brown Adipose Tissue Activity 3 mo	4.0 Standard uptake value (SUV) Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline and after 3 months of suppression

The increase in energy expenditure above resting during cold exposure

Outcome measures

Outcome measures
Measure	Estrogen Suppression n=6 Participants 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
Cold Induced Thermogenesis Baseline	350 kcal Standard Deviation 228
Cold Induced Thermogenesis 3 mo	301 kcal Standard Deviation 139

SECONDARY outcome

Timeframe: Baseline and after 3 months of suppression

Amount of body fat (in kg)

Outcome measures

Outcome measures
Measure	Estrogen Suppression n=6 Participants 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
Fat Mass Baseline	24.2 kg Standard Deviation 8.9
Fat Mass 3 mo	24.1 kg Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline and after 3 mo of suppression

Fat free mass measured by DXA

Outcome measures

Outcome measures
Measure	Estrogen Suppression n=6 Participants 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
Fat Free Mass Baseline	40.3 kg Standard Deviation 8.4
Fat Free Mass 3 mo	40.4 kg Standard Deviation 8.3

SECONDARY outcome

Timeframe: after 3 months of suppression

Energy expenditure measured in the resting state

Outcome measures

Outcome measures
Measure	Estrogen Suppression n=6 Participants 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
Resting Energy Expenditure Baseline	1382 kcal Standard Deviation 218
Resting Energy Expenditure 3 mo	1340 kcal Standard Deviation 209

Adverse Events

Estrogen Suppression

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Estrogen Suppression n=6 participants at risk 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
Reproductive system and breast disorders Vaginal Bleeding	16.7% 1/6 • Number of events 1 • 3 months
General disorders Headaches	16.7% 1/6 • Number of events 1 • 3 months

Additional Information

Edward Melanson, PhD

University of Colorado Anschutz Medical Campus

Phone: 303-724-0935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place