Short-Term Metformin Use in Young, Healthy Adults: Impacts on the Blood Lactate Response to Exercise and Time-to-exhaustion in a Placebo-controlled, Crossover Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: t
View:
• 18-30 years old
• Metformin-naïve
• BMI \< 30 kg/m2
• Recreationally active (≥ 3 days/week of exercise)
• Females must be premenopausal and report normal menstrual cycles
• Willingness and ability to comply with scheduled visits and study procedures.
Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Emily E Grammer, MS
erk9nk@uvahealth.org
434-243-8677
Backup
Macy E Stahl, MS
mes4hm@uvahealth.org
434-243-8677
Time Frame
Start Date:2025-01-31
Estimated Completion Date:2025-11-01
Participants
Target number of participants:20
Treatments
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.