EUCTR2019-004041-32-GB
Active, not recruiting
Phase 1
The effect of Canagliflozin 300mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (The CONTROL Study): A proof-of-concept, randomised, open-label, two period crossover study. - The CONTROL Study
niversity of Leicester0 sites24 target enrollmentJuly 13, 2020
DrugsInvokana
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Leicester
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age\=18 years old but less than 75 years old
- •Subjects \=1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG)
- •Able to understand written and spoken English
- •Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 22
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 2
Exclusion Criteria
- •Use of any glucose\-lowering medication (including insulin)
- •Adrenal insufficiency and/or substitution with glucocorticoids
- •ALT \>1\.5 times the upper normal limit
- •Moderate to severe renal impairment (eGFR\=60 ml/min/1\.73m2\)
- •Individuals on loop diuretics
- •Participants with established diagnosis of postural hypotension by their GP
- •Recent active infection (over the last 10 days)
- •Current use of steroids
- •Other bariatric procedure except of RYGB/SG
- •Previous revisional bariatric surgery
Outcomes
Primary Outcomes
Not specified
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