The purpose of this study is to investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese. Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss. The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Change in Body Weight
Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.
Time frame: 18 weeks (duration of study)
Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study.
Time frame: 18 weeks (duration of study)
Change in Body Composition, Measured Using DXA Scanning.
Body composition will be measured at baseline and at study completion using DXA scanning.
Time frame: 18 weeks (duration of study)
Change in Glycemic Control
Hemoglobin A1C will be measured at baseline and at study completion.
Time frame: 18 weeks (duration of study)
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