Trial Outcomes & Findings for Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (NCT NCT02927392)
NCT ID: NCT02927392
Last Updated: 2024-06-13
Results Overview
Brown adipose tissue volume will be measured using the radioactive tracer 18Fluro-deoxyglucose.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
5-6 hrs
Results posted on
2024-06-13
Participant Flow
Participant milestones
| Measure |
Pre-menopausal Women
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
25
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
16
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brown Adipose Tissue Activity in Pre- and Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Pre-menopausal Women
n=28 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 9 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8 • n=7 Participants
|
49 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5-6 hrsBrown adipose tissue volume will be measured using the radioactive tracer 18Fluro-deoxyglucose.
Outcome measures
| Measure |
Pre-menopausal Women
n=28 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Brown Adipose Tissue Volume
|
53.1 mL
Standard Deviation 42.5
|
20.6 mL
Standard Deviation 29.7
|
PRIMARY outcome
Timeframe: 5-6 hrsBrown adipose tissue activity in warm temperatures will be measured using the radioactive tracer 11C-acetate
Outcome measures
| Measure |
Pre-menopausal Women
n=26 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Brown Adipose Tissue Activity -Warm Exposure
|
.557 disintegration per min (dpm)
Standard Deviation 0.309
|
.631 disintegration per min (dpm)
Standard Deviation .283
|
PRIMARY outcome
Timeframe: 5-6 hrsBrown adipose tissue activity after cold exposure will be measured using the radioactive tracer 11C-acetate
Outcome measures
| Measure |
Pre-menopausal Women
n=27 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Brown Adipose Tissue Activity - ColdExposure
|
1.277 disintegration per minute (dpm)
Standard Deviation .851
|
.906 disintegration per minute (dpm)
Standard Deviation .544
|
SECONDARY outcome
Timeframe: 5-6 hrs.Resting energy expenditure is the calories burned when a person is at rest.
Outcome measures
| Measure |
Pre-menopausal Women
n=28 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Resting Energy Expenditure - Before Cold Exposure
|
1334 kcal/day
Standard Deviation 205
|
1223 kcal/day
Standard Deviation 189
|
SECONDARY outcome
Timeframe: 5-6 hrsResting energy expenditure is the calories burned when a person is at rest.
Outcome measures
| Measure |
Pre-menopausal Women
n=28 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Leuprolide acetate: A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
|
Post-menopausal Women
n=25 Participants
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
|
|---|---|---|
|
Resting Energy Expenditure - After Cold Exposure
|
93.6 kcal/h
Standard Deviation 25.3
|
85.0 kcal/h
Standard Deviation 19.3
|
Adverse Events
Pre-menopausal Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-menopausal Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Edward L. 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