A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
The Hospital for Sick Children
Toronto, Ontario, Canada
RECRUITINGNumber of patients with adverse events (safety and tolerability)
Time frame: 3 years
Number of patients who were approached to participate, declined participation and consented to participate (recruitment)
Time frame: 3 years
Proportion of patients who completed each visit within the trial (retention)
Time frame: 3 years
Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures)
Time frame: 3 years
Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures)
Time frame: 3 years
Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness
Time frame: 3 years
Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness
Time frame: 3 years
Optical Coherence Tomography (OCT) - Optic Nerve Head Volume
Time frame: 3 years
Visual Evoked Potentials (VEP) - p100
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.