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

NCT03200782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-10-24

No results posted yet for this study

Summary

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).

Conditions

  • Postprandial Hypoglycemia
  • Bariatric Surgery
  • Late Dumping Syndrome

Interventions

DRUG

Empagliflozin

Glucose lowering effect of empagliflozin for reducing the counter-regulatory glucose-lowering response

DRUG

Anakinra

IL-1Beta blockage effect on insulin secretion and thereby influencing postprandial glucose level

OTHER

oral placebo (winthrop tablet)

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

OTHER

subcutaneous placebo (0.67 ml of 0.9% sodium chloride)

subcutaneous placebo (0.67 ml of 0.9% sodium chloride) will be administered in arm 'Placebo-Placebo' and arm 'drug: Empagliflozin'

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Marc Donath, MD, Prof. · University Hopsital Basel

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2018-09-21
Completion
2018-09-21

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200782 on ClinicalTrials.gov