Trial Outcomes & Findings for Females, Aging, Metabolism, and Exercise (NCT NCT01712230)
NCT ID: NCT01712230
Last Updated: 2019-11-22
Results Overview
PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Change from baseline to 6 months
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
Placebo
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
18
|
18
|
|
Overall Study
COMPLETED
|
9
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Females, Aging, Metabolism, and Exercise
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
n=14 Participants
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
n=18 Participants
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Physical Activity Energy Expenditure (PAEE)
|
610 kcal/day
STANDARD_DEVIATION 315 • n=5 Participants
|
630 kcal/day
STANDARD_DEVIATION 217 • n=7 Participants
|
737 kcal/day
STANDARD_DEVIATION 295 • n=5 Participants
|
671 kcal/day
STANDARD_DEVIATION 276 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Placebo: One participant dropped because they got a new job. GnRH agonist+exercise: One participant dropped because of a health problem unrelated to the study. Results from five participants were not included in the analysis because they did not meet the exercise compliance threshold (completed \<70% of exercise sessions).
PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).
Outcome measures
| Measure |
Placebo
n=9 Participants
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
n=14 Participants
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
n=11 Participants
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
|---|---|---|---|
|
Change in Physical Activity Energy Expenditure (PAEE)
|
74.5 kcal/day
Standard Error 77.9
|
-10.2 kcal/day
Standard Error 63.6
|
61.0 kcal/day
Standard Error 66.4
|
SECONDARY outcome
Timeframe: Change over 6 monthsTotal Fat mass as measured by DXA
Outcome measures
| Measure |
Placebo
n=9 Participants
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
n=14 Participants
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
n=11 Participants
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
|---|---|---|---|
|
Total Fat Mass
|
0.73 kg
Standard Error 0.68
|
1.66 kg
Standard Error 0.41
|
0.89 kg
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Change over 6 monthsTotal Fat Free Mass as measured by DXA
Outcome measures
| Measure |
Placebo
n=9 Participants
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
n=14 Participants
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
n=11 Participants
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
|---|---|---|---|
|
Total Fat Free Mass
|
0.1 kg
Standard Error 0.34
|
-0.69 kg
Standard Error 0.34
|
-0.66 kg
Standard Error 0.59
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GnRH Agonist
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GnRH Agonist + Exercise
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Monthly placebo injections for 6 months
Placebo: Placebo
|
GnRH Agonist
n=14 participants at risk
Monthly GnRH agonist injections for 6 months
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
|
GnRH Agonist + Exercise
n=18 participants at risk
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
GnRH agonist: Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/10 • 6 Months
|
0.00%
0/14 • 6 Months
|
5.6%
1/18 • Number of events 1 • 6 Months
|
|
Endocrine disorders
Dizziness/Hot Flash
|
10.0%
1/10 • Number of events 1 • 6 Months
|
0.00%
0/14 • 6 Months
|
11.1%
2/18 • Number of events 2 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Bruising/tenderness from study procedure
|
0.00%
0/10 • 6 Months
|
7.1%
1/14 • Number of events 1 • 6 Months
|
5.6%
1/18 • Number of events 1 • 6 Months
|
|
Psychiatric disorders
Mental state change
|
0.00%
0/10 • 6 Months
|
0.00%
0/14 • 6 Months
|
5.6%
1/18 • Number of events 1 • 6 Months
|
|
General disorders
Migraine
|
10.0%
1/10 • Number of events 1 • 6 Months
|
14.3%
2/14 • Number of events 2 • 6 Months
|
0.00%
0/18 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Hamstring cramping
|
0.00%
0/10 • 6 Months
|
7.1%
1/14 • Number of events 1 • 6 Months
|
0.00%
0/18 • 6 Months
|
|
Gastrointestinal disorders
Abdominal Bloating
|
0.00%
0/10 • 6 Months
|
7.1%
1/14 • Number of events 1 • 6 Months
|
0.00%
0/18 • 6 Months
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.00%
0/10 • 6 Months
|
7.1%
1/14 • Number of events 1 • 6 Months
|
0.00%
0/18 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Itching/blistering
|
10.0%
1/10 • Number of events 1 • 6 Months
|
0.00%
0/14 • 6 Months
|
0.00%
0/18 • 6 Months
|
Additional Information
Wendy Kohrt, PhD
University of Colorado Anschutz Medical Campus
Phone: 303-724-1913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place