NCT02520518

Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Christopher Bell · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DRUG	Dapagliflozin
DRUG	Placebo
BEHAVIORAL	Weight maintenance
BEHAVIORAL	Ad libitum dietary intake
BEHAVIORAL	Dietary restriction

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-08-13
• Last updated: 2019-01-03
• Results posted: 2018-12-11

Locations

1 site across 1 country: United States