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Consequences of Hypoglycaemia on Cardiovascular and Inflammatory Responses

NCT03976271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-05-12

No results posted yet for this study

Summary

People with Type 1 diabetes (T1DM), type 2 diabetes (T2DM) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

Conditions

  • Hypoglycemia
  • Inflammatory Response
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

PROCEDURE

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Bastiaan E de Galan, MD, PhD · Radboud University Medical Center

  • Ulrik Pedersen-Bjergaard, MD, PhD · Nordsjællands University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Denmark
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03976271 on ClinicalTrials.gov