Muscle AtrophyEarly Phase 1NCT03107884
Role of Metformin on Muscle Health of Older Adults
A Early Phase 1 study testing Metformin (Bed Rest) and Metformin (2 week run-in only) in people with Muscle Atrophy and Insulin Resistance, run by University of Utah at 1 site in United States.
Trial summary
Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Insulin Resistance
- What is being tested?
- Metformin (Bed Rest) and Metformin (2 week run-in only)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60y and older
- Ability to sign informed consent
- Free-living, prior to admission
Who cannot join
- Personal history of cardiovascular disease
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, HbA1c ≥6.5%)
- Evidence of kidney disease or failure (defined as serum creatinine > 1.5mg/dL)
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes)
- Risk of Deep vein thrombosis including family history of thrombophilia, Deep vein thrombosis, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL)
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
Show all 22Show fewer
- Uncontrolled hypertension (e.g. systolic pressure >160 or a diastolic blood pressure > 100)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Currently on a weight-loss diet or body mass index > 30 kg/m2
- Inability to abstain from smoking for duration of study
- HIV or hepatitis B or C*
- Subjects excluded due to positive screening results, including HIV, hepatitis B or hepatitis C, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician.
- Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted). Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted)
- Subjects with hemoglobin or hematocrit lower than accepted lab values
- History of stroke with motor disability
- A recent history (<12 months) of GI bleed
- Depression [>5 on the 15 items Geriatric Depression Scale (GDS)]*
- This criteria will only apply to subjects in the bed rest arm.
- Liver disease (the ratio of serum aspartate aminotransferase to serum alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia) History of respiratory disease
- Currently taking estrogen products (topical vaginal products are not exclusionary (e.g. cream))
- Recent travel history as defined by 4 hours of travel by airplane in the last week
- Any other condition or event considered exclusionary by the PI and faculty physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metformin to Prevent Inactivity-induced Loss of Muscle Health During Aging
Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Metformin used as a preventive strategy to maintain muscle and metabolic health in bed ridden older adults has not been investigated.
Read the detailed description
Hospitalizations for disease, injury, and/or surgery in older adults are likely to impair physical mobility and, therefore, the older adults capacity to be physically active both during hospitalization and beyond. The resulting sedentary lifestyle is likely to be accepted as the "new normal", ultimately increasing the risk of skeletal muscle and metabolic dysfunction (e.g. insulin resistance and sarcopenia).
Muscle atrophy and insulin resistance are an unfortunate consequence with disuse in older adults. We have observed with our bed rest studies in healthy older adults that in addition to muscle and metabolic changes, we notice increased skeletal muscle inflammation, impaired glucose uptake signaling and an upregulation of enzymes related to de novo ceramide biosynthesis. The accumulation of ceramide, a toxic lipid intermediate, can disrupt glucose homeostasis and impair muscle growth. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistant adults through a mechanism that may involve ceramide synthesis. Metformin used as a preventive strategy to maintain muscle and metabolic health during a period of physical inactivity in older adults has not been investigated.
A separate group of participants for the 2-week Metformin Run-in Period, independent of the bed rest and recovery study will also be recruited. All study procedures will be the same as the 2-week Run-In period within the full protocol.
We hypothesize that metformin treatment in healthy older adults during bed rest would attenuate inflammation, insulin resistance, and thigh muscle loss and changes in lipid accumulating in muscle. We also hypothesize that elevated skeletal muscle ceramide levels, is central to the development of insulin resistance with bed rest in older adults.
Therefore, we have proposed to conduct a clinical study in older adults to:
- Test if daily metformin treatment (vs placebo) during 5d of bed rest in older adults would attenuate intramuscular ceramide accumulation (lipid accumulation), insulin resistance (euglycemic-hyperinsulinemic clamp), and loss in thigh muscle lean mass. We would also like to determine if 5-days of bed rest in older adults within the placebo group increases skeletal muscle ceramide concentrations and whether these are in turn associated with insulin resistance.
- Test if daily metformin treatment (vs placebo) during 5d of bed rest in older adults would improve skeletal muscle glucose uptake cell signaling, reduce skeletal muscle inflammation and ceramide biosynthesis signaling.
- Determine if muscle ceramides and insulin resistance return to baseline levels following 7 days of recovery after bed rest in the placebo group.
- Determine if metformin given over a 2 week period (independent of bed rest) will improve muscle size, strength and insulin sensitivity.
- Determine if metformin improves the recovery of muscle size and strength and insulin sensitivity 7 days after bed rest.
These findings will be foundational for future development of treatments to prevent insulin resistance and muscle atrophy in inactive older adults.
- Conditions
- Muscle Atrophy, Insulin Resistance
- Being tested
- Metformin (Bed Rest), Placebo (Bed Rest), Metformin (2 week run-in only), Placebo (2 week run-in only)
- Keywords
- Insulin Resistance, Muscle Atrophy, Metformin, Muscle Loss, Inactivity-induced muscle loss, older adults
- Medical subject headings
- Muscular Atrophy, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin (Bed Rest)Drug
Also called Metformin hydrochloride, Fortamet, glucophage, Glumetza
A clinical oral dose of Metformin will be given to participant daily during bed rest
Placebo (Bed Rest)Drug
Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin treatment group
Metformin (2 week run-in only)Drug
Also called Metformin hydrochloride, Fortamet, Glucophage, Glumetza
A clinical oral dose of Metformin will be given to participant daily during a two week run-in period only.
Placebo (2 week run-in only)Drug
Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin 2 week run-in treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Metformin (Bed Rest) | Experimental | Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). During bed rest, participants will be given 1 gram of metformin two times a day (morning and evening). This dosage and frequency will occur during four consecutive days of bed rest. Receives: Drug: Metformin (Bed Rest) |
| Placebo (Bed Rest) | Placebo comparator | Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. During bed rest, participants will be given the same amount of pills and given at the same time of day (morning and evening) as the experimental group. This strategy will occur during four consecutive days of bed rest. Receives: Drug: Placebo (Bed Rest) |
| Metformin (2 week run-in only) | Experimental | Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). These participants will not participate in the bed rest portion of the protocol. Receives: Drug: Metformin (2 week run-in only) |
| Placebo (2 week run-in only) | Placebo comparator | Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. These participants will not participate in the bed rest portion of the protocol. Receives: Drug: Placebo (2 week run-in only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle size
Change in muscle size from baseline to 5-days of bed rest (determined from MRI)
Measured: Change in muscle size from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Insulin sensitivity
Change in insulin sensitivity from baseline to 5-days of bed rest (determined from glucose infusion rate)
Measured: Change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Aug 2019
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107884
- Sponsor's protocol ID
- 93579
- Status last verified
- Dec 2025
- First submitted
- 22 Mar 2017
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrocelli JJ, McKenzie AI, de Hart NMMP, Reidy PT, Mahmassani ZS, Keeble AR, Kaput KL, Wahl MP, Rondina MT, Marcus RL, Welt CK, Holland WL, Funai K, Fry CS, Drummond MJ. Disuse-induced muscle fibrosis, cellular senescence, and senescence-associated secretory phenotype in older adults are alleviated during re-ambulation with metformin pre-treatment. Aging Cell. 2023 Nov;22(11):e13936. doi: 10.1111/acel.13936. Epub 2023 Jul 24.
PubMed 37486024Petrocelli JJ, de Hart NMMP, Lang MJ, Yee EM, Ferrara PJ, Fix DK, Chaix A, Funai K, Drummond MJ. Cellular senescence and disrupted proteostasis induced by myotube atrophy are prevented with low-dose metformin and leucine cocktail. Aging (Albany NY). 2023 Mar 20;15(6):1808-1832. doi: 10.18632/aging.204600. Epub 2023 Mar 20.
PubMed 36947713McKenzie AI, Mahmassani ZS, Petrocelli JJ, de Hart NMMP, Fix DK, Ferrara PJ, LaStayo PC, Marcus RL, Rondina MT, Summers SA, Johnson JM, Trinity JD, Funai K, Drummond MJ. Short-term exposure to a clinical dose of metformin increases skeletal muscle mitochondrial H2O2 emission and production in healthy, older adults: A randomized controlled trial. Exp Gerontol. 2022 Jun 15;163:111804. doi: 10.1016/j.exger.2022.111804. Epub 2022 Apr 9.
PubMed 35405248
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin to Prevent Inactivity-induced Loss of Muscle Health During Aging
- ClinicalTrials.gov ID
- NCT03107884
- Acronym / sponsor ID
- 93579
- Conditions
- Muscle Atrophy, Insulin Resistance
- Keywords
- Insulin Resistance, Muscle Atrophy, Metformin, Muscle Loss, Inactivity-induced muscle loss, older adults
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Metformin used as a preventive strategy to maintain muscle and metabolic health in bed ridden older adults has not been investigated.
Detailed description
Hospitalizations for disease, injury, and/or surgery in older adults are likely to impair physical mobility and, therefore, the older adults capacity to be physically active both during hospitalization and beyond. The resulting sedentary lifestyle is likely to be accepted as the "new normal", ultimately increasing the risk of skeletal muscle and metabolic dysfunction (e.g. insulin resistance and sarcopenia).
Muscle atrophy and insulin resistance are an unfortunate consequence with disuse in older adults. We have observed with our bed rest studies in healthy older adults that in addition to muscle and metabolic changes, we notice increased skeletal muscle inflammation, impaired glucose uptake signaling and an upregulation of enzymes related to de novo ceramide biosynthesis. The accumulation of ceramide, a toxic lipid intermediate, can disrupt glucose homeostasis and impair muscle growth. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistant adults through a mechanism that may involve ceramide synthesis. Metformin used as a preventive strategy to maintain muscle and metabolic health during a period of physical inactivity in older adults has not been investigated.
A separate group of participants for the 2-week Metformin Run-in Period, independent of the bed rest and recovery study will also be recruited. All study procedures will be the same as the 2-week Run-In period within the full protocol.
We hypothesize that metformin treatment in healthy older adults during bed rest would attenuate inflammation, insulin resistance, and thigh muscle loss and changes in lipid accumulating in muscle. We also hypothesize that elevated skeletal muscle ceramide levels, is central to the development of insulin resistance with bed rest in older adults.
Therefore, we have proposed to conduct a clinical study in older adults to:
- Test if daily metformin treatment (vs placebo) during 5d of bed rest in older adults would attenuate intramuscular ceramide accumulation (lipid accumulation), insulin resistance (euglycemic-hyperinsulinemic clamp), and loss in thigh muscle lean mass. We would also like to determine if 5-days of bed rest in older adults within the placebo group increases skeletal muscle ceramide concentrations and whether these are in turn associated with insulin resistance.
- Test if daily metformin treatment (vs placebo) during 5d of bed rest in older adults would improve skeletal muscle glucose uptake cell signaling, reduce skeletal muscle inflammation and ceramide biosynthesis signaling.
- Determine if muscle ceramides and insulin resistance return to baseline levels following 7 days of recovery after bed rest in the placebo group.
- Determine if metformin given over a 2 week period (independent of bed rest) will improve muscle size, strength and insulin sensitivity.
- Determine if metformin improves the recovery of muscle size and strength and insulin sensitivity 7 days after bed rest.
These findings will be foundational for future development of treatments to prevent insulin resistance and muscle atrophy in inactive older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin (Bed Rest) | Experimental | Drug: Metformin (Bed Rest)Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). During bed rest, participants will be given 1 gram of metformin two times a day (morning and evening). This dosage and frequency will occur during four consecutive days of bed rest. |
| Placebo (Bed Rest) | Placebo comparator | Drug: Placebo (Bed Rest)Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. During bed rest, participants will be given the same amount of pills and given at the same time of day (morning and evening) as the experimental group. This strategy will occur during four consecutive days of bed rest. |
| Metformin (2 week run-in only) | Experimental | Drug: Metformin (2 week run-in only)Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). These participants will not participate in the bed rest portion of the protocol. |
| Placebo (2 week run-in only) | Placebo comparator | Drug: Placebo (2 week run-in only)Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. These participants will not participate in the bed rest portion of the protocol. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60y and older
- Ability to sign informed consent
- Free-living, prior to admission
Key exclusion criteria (22 listed)
- Personal history of cardiovascular disease
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, HbA1c ≥6.5%)
- Evidence of kidney disease or failure (defined as serum creatinine > 1.5mg/dL)
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes)
- Risk of Deep vein thrombosis including family history of thrombophilia, Deep vein thrombosis, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin (Bed Rest)Also: Metformin hydrochloride, Fortamet, glucophage, GlumetzaA clinical oral dose of Metformin will be given to participant daily during bed rest | Drug | Metformin (Bed Rest) |
| Placebo (Bed Rest)Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin treatment group | Drug | Placebo (Bed Rest) |
| Metformin (2 week run-in only)Also: Metformin hydrochloride, Fortamet, Glucophage, GlumetzaA clinical oral dose of Metformin will be given to participant daily during a two week run-in period only. | Drug | Metformin (2 week run-in only) |
| Placebo (2 week run-in only)Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin 2 week run-in treatment group. | Drug | Placebo (2 week run-in only) |
Primary outcome
Muscle size
Time frame: Change in muscle size from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Change in muscle size from baseline to 5-days of bed rest (determined from MRI)
Insulin sensitivity
Time frame: Change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Change in insulin sensitivity from baseline to 5-days of bed rest (determined from glucose infusion rate)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 37486024Petrocelli JJ, McKenzie AI, de Hart NMMP, Reidy PT, Mahmassani ZS, Keeble AR, Kaput KL, Wahl MP, Rondina MT, Marcus RL, Welt CK, Holland WL, Funai K, Fry CS, Drummond MJ. Disuse-induced muscle fibrosis, cellular senescence, and senescence-associated secretory phenotype in older adults are alleviated during re-ambulation with metformin pre-treatment. Aging Cell. 2023 Nov;22(11):e13936. doi: 10.1111/acel.13936. Epub 2023 Jul 24.
- Derived from this study: PubMed 36947713Petrocelli JJ, de Hart NMMP, Lang MJ, Yee EM, Ferrara PJ, Fix DK, Chaix A, Funai K, Drummond MJ. Cellular senescence and disrupted proteostasis induced by myotube atrophy are prevented with low-dose metformin and leucine cocktail. Aging (Albany NY). 2023 Mar 20;15(6):1808-1832. doi: 10.18632/aging.204600. Epub 2023 Mar 20.
- Derived from this study: PubMed 35405248McKenzie AI, Mahmassani ZS, Petrocelli JJ, de Hart NMMP, Fix DK, Ferrara PJ, LaStayo PC, Marcus RL, Rondina MT, Summers SA, Johnson JM, Trinity JD, Funai K, Drummond MJ. Short-term exposure to a clinical dose of metformin increases skeletal muscle mitochondrial H2O2 emission and production in healthy, older adults: A randomized controlled trial. Exp Gerontol. 2022 Jun 15;163:111804. doi: 10.1016/j.exger.2022.111804. Epub 2022 Apr 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micah Drummond principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin (Bed Rest) and Metformin (2 week run-in only) in people with Muscle Atrophy and Insulin Resistance, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle size (time frame: Change in muscle size from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107884, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.