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Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation

NCT03460899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-11-18

Study results available
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Summary

This experimental study is planned to investigate the impact of hypoglycaemia on platelet activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. The hypothesis that hypoglycaemia in patients with Diabetes Mellitus, Type 2 (T2DM) leads to increased platelet activation will be tested.

Conditions

  • Diabetes Mellitus With Hypoglycemia
  • Diabetes Mellitus, Type 2
  • Hypoglycemia
  • Hypoglycemic Episode

Interventions

OTHER

Euglycaemic Clamp

All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)

OTHER

Hyperinsulinaemic/Hypoglycaemic Clamp

All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)

Sponsors & Collaborators

Principal Investigators

  • Harald Sourij · Medical University of Graz, Division of Endocrinology and Diabetology

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-06-11
Completion
2018-06-11

Countries

  • Austria

Study Locations

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Diseases
Companies

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 NCT03460899 on ClinicalTrials.gov