Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT03200782
Status
Completed

Conditions

  • Bariatric Surgery
  • Late Dumping Syndrome
  • Postprandial Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Glucose lowering effect of empagliflozin for reducing the counter-regulatory glucose-lowering response
  • Anakinra — DRUG
    IL-1Beta blockage effect on insulin secretion and thereby influencing postprandial glucose level
  • oral placebo (winthrop tablet) — OTHER
    subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
  • subcutaneous placebo (0.67 ml of 0.9% sodium chloride) — OTHER
    subcutaneous placebo (0.67 ml of 0.9% sodium chloride) will be administered in arm 'Placebo-Placebo' and arm 'drug: Empagliflozin'

Study Details

The purpose of the study is to investigate whether hypoglycaemia observed after food intake in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA, anakinra).

Key Dates

Start date
May 30, 2017
Status verified
Oct 2018
Primary completion
Sep 21, 2018
Completion
Sep 21, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Placebo Comparator: Placebo-Placebo
    subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
  • Active Comparator: Investigational Drug A Empagliflozin
    subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an 10mg of empagliflozin 2 hours before the test meal will be administered by an independent nurse to the blinded patient
  • Active Comparator: Investigational Drug B Anakinra
    subcutaneous injection of 100mg anakinra 3 hours before the test meal and an oral placebo (winthrop tablet)before the test meal will be administered by an Independent nurse to the blinded patient

Primary Outcome Measure

Postprandial hypoglycemia in patients after bariatric surgery [ Time Frame: 6 hours ]

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