Post-bariatric hypoglycaemia
Conditions
Interventions
Trade Name: Glucobay
Product Name: acarbose
Pharmaceutical Form: Tablet
INN or Proposed INN: ACARBOSE
CAS Number: 56180-94-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At enrolment, participants must: • Be adults (above 18 years old); • Have undergone bariatric surgery more than 18 months prior to inclusion; • Self-reported weight stability (less than 5% variation over the 6 months); • Present at least one 5-minutes or longer event of interstitial fluid glucose =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All patients presenting one of the following at enrolment will be excluded: • Altered baseline analytical profile, namely an early morning 12h-fasting blood test with hemogram, liver and kidney functions tests, albumin, total proteins, plasma glucose, TSH, insulin, C-peptide, and beta-hCG and thus pointing towards other potential causes for hypoglycaemia and/or prone to unsafety to pursue the trial*; • Inability or unwillingness to perform meal test (e.g. unable to have the meal over 20 minutes); • Pharmacotherapy that affects glucose metabolism: • Glucocorticoid treatment within 6 weeks of inclusion; • Somatostatin analogue treatment within 4 months of inclusion; • GLP-1 receptor analogue treatment within 6 half-lives of inclusion; • SGLT2 inhibitor treatment within 2 weeks of inclusion. • HbA1c >47.5 mmol/mol [>6.5%;] • Antithyroid treatment within 3 months of inclusion or poorly managed thyroid disease (TSH outside reference range); • Pregnancy (positive pregnancy test), aspiring to get pregnant over the following 5 months or lactation; • Renal insufficiency (eGFR 3 x elevation of upper normal limit of alanine amino transferase and/or alkaline phosphatases); • Poorly controlled psychiatric disease or mental retardation; • Alcohol or other substance abuse; • Significant anaemia (Hb <6.0 mmol/L); • Recent history of major adverse cardiovascular events (MACE), such as hospitalizations for heart failure, nonfatal stroke, or nonfatal myocardial infarction within the previous 12 months; • Any other condition that in the opinion of the investigator may compromise outcome; • Sustained intolerance to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether canagliflozin/acarbose therapy is an effective treatment for post-bariatric hypolgycaemia (PBH).;Secondary Objective: To explore how chronic treatment with canagliflozin/acarbose modulates the response to a standard meal; To clarify if there is a correlation between PBH symptomatology, glycaemic variability and electrocardiographic findings, and whether these are modulated by treatment interventions. ;Primary end point(s): oTime under level 1 hypoglycaemia (IFG <3.9 mmol/L or <70 mg/dL) throughout CGM evaluation, comparing treatment intervention A (canagliflozin) and B (acarbose) against treatment intervention C (placebo).;Timepoint(s) of evaluation of this end point: Last 10-14 days of each treatment intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time under level 2 hypoglycaemia (IFG <3.0 mmol/L or <54 mg/dL) throughout CGM evaluation, comparing treatment interventions A and B against C; - Postprandial nadir glucose during the meal test, comparing treatment interventions A and B against C;;Timepoint(s) of evaluation of this end point: Last 10-14 days of each treatment intervention. | — |
Countries
Denmark
Contacts
Public ContactCarolina Brito Lobato
Carolina Brito Lobato
Outcome results
None listed