The effect of canagliflozin 300mg on glucose levels in people without diabetes after weight loss surgery.

Phase 1

• Conditions: Postprandial hypoglycaemia after bariatric surgery; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-004041-32-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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
•Currently pregnant or breastfeeding
•Females of child-bearing age, unwilling to use contraception during the period of the study
•Patients with history of Type 1 or Type 2 diabetes
• Intolerant to the Mixed Meal Tolerance test.
•HbA1C = 6.5% or =48mmol/l at screening blood tests
•Haemoglobin (Hb) <100 g/L at screening blood tests
•Clinical contraindication to Canagliflozin
•Known osteoporosis
•Previous history of Fournier’s gangrene
• History of epilepsy
•Known foot ulcers/previous amputation
•Participating in another research study involving intervention within 3 months of screening
•Having a formal previous diagnosis of postprandial hypoglycaemia
•Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
•Participants without established previous diagnosis of postprandial hyperinsulinaemic hypoglycaemia but with symptoms suggestive of frequent (defined as more than once weekly) AND severe postprandial hypoglycaemia at the screening hypoglycaemia questionnaire (severe is defined as at least 2 symptom on Edinburgh Hypoglycaemia Scale (EHS) Questionnaire with intensity >5 in a scale from 1 to 7) over the last 2 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified