Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06638671
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Exercise Capacity
  • Metformin

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Participants will consume metformin or placebo in a randomized order. Participants will complete exercise visits during each treatment phase.
  • Placebo — DRUG
    Participants will consume metformin or placebo in a randomized order. Participants will complete exercise visits during each treatment phase.

Study Details

Metformin is the most prescribed blood sugar (glucose)-lowering medication for patients diagnosed with type 2 diabetes mellitus (T2DM). Metformin stimulates glucose uptake in skeletal muscle similar to the effects of exercise, though, some studies report that metformin may decrease exercise capacity. The main question this study looks to answer is: • Does metformin alter exercise capacity? Participants will: * Complete 5 exercise tests on a stationary bike. * Undergo a body composition test. * Take metformin and placebo. * Complete food and symptom logs. The researchers hypothesize that: • Metformin will reduce aerobic capacity.

Key Dates

Start date
Jan 31, 2025
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin (MET)
    At the end of the screening visit, participants will be randomized to either Condition A or Condition B (MET or PL first). Participants will begin the 19-day treatment phase of study the day after screening. During each treatment phase, participants will consume metformin as follows: 1x500 mg tablet/day for 5 days, 2x500 mg tablets/day for 5 days, and 3x500 mg tablets/day (or maximally tolerated dosage) for 9 days. Participants will then complete a VO2peak/LT test on day 16, rest for 48 hours, then complete a time-to-exhaustion test (day 19) during the final days of the treatment phase. After the time-to-exhaustion test, participants will begin the placebo treatment phase.
  • Placebo Comparator: Placebo (PL)
    At the end of the screening visit, participants will be randomized to either Condition A or Condition B (MET or PL first). Participants will begin the 19-day treatment phase of study the day after screening. During each treatment phase, participants will consume placebo as follows: 1x500 mg tablet/day for 5 days, 2x500 mg tablets/day for 5 days, and 3x500 mg tablets/day (or maximally tolerated dosage) for 9 days. Participants will then complete a VO2peak/LT test on day 16, rest for 48 hours, then complete a time-to-exhaustion test (day 19) during the final days of the treatment phase. After the time-to-exhaustion test, participants will begin the metformin treatment phase.

Primary Outcome Measure

Exercise capacity [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903-

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University of Virginia· Charlottesville, VA

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