Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors 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. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.
This is a randomized, prospective, placebo-controlled, double blind, repeated measures study. 50 overweight/obese adults (body mas index \> 27.5 kg/m2) will be recruited for participation and randomly assigned to one of two 12 week treatments: (1) daily oral administration of Dapagliflozin with dietary counseling to promote weight loss; or, (2) daily oral administration of a placebo with dietary counseling to promote weight loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
62
Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
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
Insulin sensitivity was estimated by measuring circulating insulin concentrations after a 12 hour fast and after ingesting 75 g of glucose. Insulin was measured 0, 30, 60, 90 and 120 minutes after glucose ingestion. Time point 0 minutes is reported below.
Time frame: Baseline, 12 weeks
Change From Baseline in Blood Pressure at Week 12
Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic
Time frame: Baseline, 12 weeks
Change From Baseline in Perception of Satiety at Week 12
Participants answered a satiety questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses how full do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How full do you feel right now)? Answer 0: Not full at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely full. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented a decreased desire to eat.
Time frame: Baseline, 12 weeks
Change From Baseline in Perception of Hunger at Week 12
Participants answered a hunger questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses to how hungry do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How hungry do you feel right now? Answer 0: Not hungry at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely hungry. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented an increased desire to eat.
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: Data not collected
Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Data not collected
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: data not collected
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: data not collected
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: data not collected
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: Data not collected
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: Data not collected
Change From Baseline in Satiety Hormone Leptin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Data not collected
Change From Baseline in Satiety Hormone Insulin at Week 12
Will be analyzed using a commercially available biochemical assay.
Time frame: Data not collected
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