Trial · NCT01712230
Females, Aging, Metabolism, and Exercise
NCT01712230, Not applicable, Completed, University of Colorado, Denver; results first posted 2019-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Females, Aging, Metabolism, and Exercise. Trials, record NCT01712230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Females, Aging, Metabolism, and Exercise
- NCT number
- NCT01712230
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Obesity
- Interventions
- GnRH agonist, Supervised cardiovascular exercise, Placebo
- First posted
- 2012-10-23
- Last updated
- 2019-11-22
- Results first posted
- 2019-11-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Physical Activity Energy Expenditure (PAEE) | Change from baseline to 6 months | 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). |
| Secondary | Total Fat Mass | Change over 6 months | Total Fat mass as measured by DXA |
| Secondary | Total Fat Free Mass | Change over 6 months | Total Fat Free Mass as measured by DXA |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Physical Activity Energy Expenditure (PAEE) | Change from baseline to 6 months | 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). | kcal/day | MEAN |
| SECONDARY | Total Fat Mass | Change over 6 months | kg | MEAN | |
| SECONDARY | Total Fat Free Mass | Change over 6 months | kg | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Physical Activity Energy Expenditure (PAEE) | Placebo | 74.5 | Standard Error 77.9 | kcal/day | |
| Change in Physical Activity Energy Expenditure (PAEE) | GnRH Agonist | -10.2 | Standard Error 63.6 | kcal/day | |
| Change in Physical Activity Energy Expenditure (PAEE) | GnRH Agonist + Exercise | 61.0 | Standard Error 66.4 | kcal/day | |
| Total Fat Mass | Placebo | 0.73 | Standard Error 0.68 | kg | |
| Total Fat Mass | GnRH Agonist | 1.66 | Standard Error 0.41 | kg | |
| Total Fat Mass | GnRH Agonist + Exercise | 0.89 | Standard Error 0.60 | kg | |
| Total Fat Free Mass | Placebo | 0.1 | Standard Error 0.34 | kg | |
| Total Fat Free Mass | GnRH Agonist | -0.69 | Standard Error 0.34 | kg | |
| Total Fat Free Mass | GnRH Agonist + Exercise | -0.66 | Standard Error 0.59 | kg |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | STARTED | GnRH Agonist | 18 | |
| Overall Study | STARTED | GnRH Agonist + Exercise | 18 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | COMPLETED | GnRH Agonist | 14 | |
| Overall Study | COMPLETED | GnRH Agonist + Exercise | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | GnRH Agonist | 4 | |
| Overall Study | NOT COMPLETED | GnRH Agonist + Exercise | 7 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea/vomiting | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Nausea/vomiting | Gastrointestinal disorders | GnRH Agonist | 0 | 14 | 0 |
| other | Nausea/vomiting | Gastrointestinal disorders | GnRH Agonist + Exercise | 1 | 18 | 1 |
| other | Dizziness/Hot Flash | Endocrine disorders | Placebo | 1 | 10 | 1 |
| other | Dizziness/Hot Flash | Endocrine disorders | GnRH Agonist | 0 | 14 | 0 |
| other | Dizziness/Hot Flash | Endocrine disorders | GnRH Agonist + Exercise | 2 | 18 | 2 |
| other | Bruising/tenderness from study procedure | Skin and subcutaneous tissue disorders | Placebo | 0 | 10 | 0 |
| other | Bruising/tenderness from study procedure | Skin and subcutaneous tissue disorders | GnRH Agonist | 1 | 14 | 1 |
| other | Bruising/tenderness from study procedure | Skin and subcutaneous tissue disorders | GnRH Agonist + Exercise | 1 | 18 | 1 |
| other | Mental state change | Psychiatric disorders | Placebo | 0 | 10 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, all-cause mortality | GnRH Agonist | 0 | 14 |
| Total, all-cause mortality | GnRH Agonist + Exercise | 0 | 18 |
| Total, other adverse events | Placebo | 3 | 10 |
| Total, other adverse events | GnRH Agonist | 4 | 14 |
| Total, other adverse events | GnRH Agonist + Exercise | 4 | 18 |
| Total, serious adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | GnRH Agonist | 0 | 14 |
| Total, serious adverse events | GnRH Agonist + Exercise | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33150745 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50HD073063 | Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function | KOHRT, WENDY M | UNIVERSITY OF COLORADO DENVER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2012 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01712230
GET https://conductscience.org/api/trials/v1/NCT01712230/events?page=2