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Clinical Trials/ISRCTN11342830
ISRCTN11342830
Completed
未知

The effect of canagliflozin 300 mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (the CONTROL study): a proof-of-concept, randomised, open-label, two-period crossover study

niversity of Leicester0 sites36 target enrollmentJuly 24, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Hypoglycaemia after eating due to weight-loss surgery
Sponsor
niversity of Leicester
Enrollment
36
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 24, 2020
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leicester

Eligibility Criteria

Inclusion Criteria

  • 1\. Age \=18 years old but less than 75 years old
  • 2\. \=1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG)
  • 3\. Able to understand written and spoken English
  • 4\. Able to give informed consent

Exclusion Criteria

  • 1\. Use of any glucose\-lowering medication (including insulin)
  • 2\. Adrenal insufficiency and/or substitution with glucocorticoids
  • 3\. ALT \> 1\.5 times the upper normal limit
  • 4\. Moderate to severe renal impairment (eGFR\< \= 60 ml/min/1\.73m2\)
  • 5\. Individuals on loop diuretics
  • 6\. Participants with established diagnosis of postural hypotension by their GP
  • 7\. Recent active infection (over the last 10 days)
  • 8\. Current use of steroids
  • 9\. Other bariatric procedure except RYGB/SG
  • 10\. Previous revisional bariatric surgery

Outcomes

Primary Outcomes

Not specified

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