Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2) inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood pressure, decreased inflammation, and decreased oxidative stress. It is unclear as to whether these health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.
This is a randomized, prospective, placebo-controlled, double-blind, repeated measures study. 92 overweight/obese adults (body mas index \> 27.5 kg/m\^2) will be recruited for participation and randomly assigned to one of four 12 week treatments: 1) daily oral administration of dapagliflozin with ad-libitum dietary intake; 2) daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance; 3) daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in treatment 1; or, 4) daily oral administration of a placebo with ad-libitum dietary intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
9
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, United States
Change From Baseline in Insulin Sensitivity at Week 12
Via oral glucose tolerance test.
Time frame: Baseline,12 weeks
Change From Baseline in Blood Pressure at Week 12
Time frame: Baseline, 12 weeks
Change From Baseline in Perception of Satiety at Week 12
Perceptions of satiety will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all full) and the maximum value is 100 (extremely full). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived satiety. If Dapagliflozin were effective at increasing fullness, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.
Time frame: Baseline, 12 weeks
Change From Baseline in Perception of Hunger at Week 12
Perceptions of Hunger will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all hungry) and the maximum value is 100 (very hungry). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived hunger. If Dapagliflozin were effective at decreasing hunger, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.
Time frame: Baseline, 12 weeks
Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
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Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Satiety Hormone Leptin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks
Change From Baseline in Satiety Hormone Insulin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Baseline, 12 weeks