Trial · NCT02308228
Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
NCT02308228, Early phase 1, Completed, Philip Kern; results first posted 2019-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin to Augment Strength Training Effective Response in Seniors (MASTERS). Trials, record NCT02308228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02308228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
- NCT number
- NCT02308228
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 109 participants, actual
- Lead sponsor
- Philip Kern
- Conditions
- Aging
- Interventions
- Progressive Resistance Training, Metformin
- First posted
- 2014-12-04
- Last updated
- 2019-09-17
- Results first posted
- 2019-09-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Type 2 Myofiber Cross Sectional Area | 16 weeks | The ability of metformin to improve the hypertrophic response to resistance training will be determined. Muscle biopsies of the vastus lateralis will be used to quantify myofiber cross-sectional area. The percent change in type 2 myofiber size between week 16 and week 0 was used. |
| Secondary | Percent Change in Normal Density Muscle Size by Computed Tomography | 16 weeks | The ability of metformin to improve the hypertrophic response at the whole muscle level will be quantified by computed tomography. Percent change in normal density muscle area will be calculated as the difference between week 16 and week 0. |
| Other | Percent Change in Muscle Strength | Week 4 and week 16 | Determine if metformin treatment augments strength gains in conjunction with progressive resistance training by one repetition maximum assessments. Maximum (1RM) leg extension muscle strength was assessed at week 4 (to account for neurological adaptations during the initial stages of the resistance program) and week 16. The percent change from week 4 to week 16 is reported. |
| Other | Percent Change in Total Body Lean Mass by DXA | 16 weeks | To determine if metformin improves changes in body composition associated with progressive resistance training. Percent change in total body lean mass in kg was calculated as the difference between week 16 and week 0 from a total body DXA scan. |
| Other | Insulin Sensitivity | 16 weeks | A standard OGTT will be used to determine insulin sensitivity using the Matsuda Index. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Type 2 Myofiber Cross Sectional Area | 16 weeks | The largest, highest quality pairs of baseline and week 16 mounts were used for quantification of immunohistochemistry (N=30/group) | Percent change | MEAN |
| SECONDARY | Percent Change in Normal Density Muscle Size by Computed Tomography | 16 weeks | Missing data points include those who, based on femur area, CT positioning at post measure was incorrect = 16. In addition, 1 subject was excluded from analysis as CT data indicated 45% loss of thigh muscle area, which was not consistent with other data for this subject. | Percent change | MEAN |
| OTHER_PRE_SPECIFIED | Percent Change in Muscle Strength | Week 4 and week 16 | Some participants were not able to complete the procedure on the day of testing, injured etc | Percent change | MEAN |
| OTHER_PRE_SPECIFIED | Percent Change in Total Body Lean Mass by DXA | 16 weeks | Analysis of lean muscle mass for those who completed the interventions. | Percent change | MEAN |
| OTHER_PRE_SPECIFIED | Insulin Sensitivity | 16 weeks |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Type 2 Myofiber Cross Sectional Area | Metformin | 18.5 | Standard Deviation 31.5 | Percent change | |
| Percent Change in Type 2 Myofiber Cross Sectional Area | Placebo, Sugar Pill | 14.5 | Standard Deviation 29.7 | Percent change | |
| Percent Change in Normal Density Muscle Size by Computed Tomography | Metformin | 4.2 | Standard Deviation 9.1 | Percent change | |
| Percent Change in Normal Density Muscle Size by Computed Tomography | Placebo, Sugar Pill | 10.5 | Standard Deviation 7.0 | Percent change | |
| Percent Change in Muscle Strength | Metformin | 15.3 | Standard Deviation 18.5 | Percent change | |
| Percent Change in Muscle Strength | Placebo, Sugar Pill | 23.1 | Standard Deviation 18.9 | Percent change | |
| Percent Change in Total Body Lean Mass by DXA | Metformin | 0.41 | Standard Deviation 2.25 | Percent change | |
| Percent Change in Total Body Lean Mass by DXA | Placebo, Sugar Pill | 1.95 | Standard Deviation 2.69 | Percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 54 | |
| Overall Study | STARTED | Placebo, Sugar Pill | 55 | |
| Overall Study | COMPLETED | Metformin | 46 | |
| Overall Study | COMPLETED | Placebo, Sugar Pill | 48 | |
| Overall Study | NOT COMPLETED | Metformin | 8 | |
| Overall Study | NOT COMPLETED | Placebo, Sugar Pill | 7 |
Source ClinicalTrials.gov
Adverse events4
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, Diarrhea, Flatulence | Gastrointestinal disorders | Metformin | 17 | 54 | 18 |
| other | Nausea, Diarrhea, Flatulence | Gastrointestinal disorders | Placebo, Sugar Pill | 1 | 55 | 1 |
| other | Musculoskeletal Pain or Injury | Musculoskeletal and connective tissue disorders | Metformin | 4 | 54 | 4 |
| other | Musculoskeletal Pain or Injury | Musculoskeletal and connective tissue disorders | Placebo, Sugar Pill | 5 | 55 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | 0 | 54 |
| Total, all-cause mortality | Placebo, Sugar Pill | 0 | 55 |
| Total, other adverse events | Metformin | 17 | 54 |
| Total, other adverse events | Placebo, Sugar Pill | 6 | 55 |
| Total, serious adverse events | Metformin | 0 | 54 |
| Total, serious adverse events | Placebo, Sugar Pill | 0 | 55 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R01AG046920 | Novel Actions of Metformin to Augment Resistance Training Adaptations in Older Ad | PETERSON, CHARLOTTE A.; BAMMAN, MARCAS M; KERN, PHILIP A | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON AGING | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin vs Placebo, Sugar Pill: deaths from any cause | Trial comparisons |
| Metformin vs Placebo, Sugar Pill: serious adverse events | Trial comparisons |
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/NCT02308228
GET https://conductscience.org/api/trials/v1/NCT02308228/registered