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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03460899 |
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Date of registration:
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22/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
Diaplate |
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Scientific title:
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Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation |
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Date of first enrolment:
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February 12, 2018 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03460899 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Harald Sourij |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Graz, Division of Endocrinology and Diabetology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female aged 18-64 years (both inclusive) at the time of signing informed
consent
- Subjects diagnosed with type 2 diabetes (diagnosed regarding world health organization
[WHO] criteria) and on stable treatment for a period of 90 days prior to screening
with metformin as monotherapy or diet only. Stable is defined as unchanged dose
- Body mass index (BMI) between 20.0 and 35.0 kg/m2 (both inclusive)
- HbA1c between 43 and 64 mmol/mol (6.0% - 8.0%) (both inclusive)
- No use of platelet inhibiting therapy (e.g. aspirin, clopidogrel, ticagrelor,
prasugrel)
Exclusion Criteria:
- All other forms of diabetes (type 1 diabetes, gestational diabetes) than type 2
diabetes mellitus
- Treatment with any glucose lowering agent(s) other than metformin in a period of 60
days before screening. An exception is short-term treatment (= 7 days in total) with
insulin due to intercurrent illness
- Impaired hypoglycaemic awareness determined at the discretion of the investigator
- Medical history of arrhythmia as atrial fibrillation, atrial flutter, atrioventricular
dissociation disorders or ventricular arrhythmias
- Previously known cardiovascular disease and / or past cardiovascular events, or past
episodes of a congestive heart failure syndrome (NYHA II - NYHA IV)
- Severe hypoglycaemic event requiring third party help in the last 6 months
- Known allergy to human insulin or dextrose solution
- Clinically significant abnormal haematology, biochemistry, lipids, hormones,
coagulation or urinalysis
- Uncontrolled hypertension defined as resting blood pressure at screening (after
resting for 5 min, measured in sitting position) outside the range of 90-160 mmHg for
systolic or 50-100 mmHg for diastolic
- Chronic liver failure with severe liver dysfunction as assessed by the investigator
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) levels > 3x upper
Limit of normal (ULN)
- estimated Glomerular Filtration Rate (eGFR) <45 ml/min/1,73 m2
- Any musculoskeletal disorders holding back from stay in bed in a lying position during
the time of the clamp experiments
- Treatment with beta-blockers, antiarrhythmic agents or neuroleptic drugs
- Active smoker or intake of illicit substances
- Regular intake of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Any mental disorders or psychiatric conditions which may interfere with understanding
or conduction of study related procedures
- Females of child bearing potential without adequate contraceptive methods (i.e.
sterilisation, intrauterine device, vasectomised partner; or medical history of
hysterectomy)
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Hypoglycemic Episode
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Diabetes Mellitus With Hypoglycemia
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Hypoglycemia
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Intervention(s)
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Other: Hyperinsulinaemic/Hypoglycaemic Clamp
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Other: Euglycaemic Clamp
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Primary Outcome(s)
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Changes in Platelet Activation Marker Adenosin Diphosphate (%)
[Time Frame: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment]
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Secondary Outcome(s)
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Changes in Coagulation Marker Fibrinogen (g/L)
[Time Frame: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment]
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Quantification of Platelet Function and Activation PAC1CD62PCD63POS (%)
[Time Frame: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment]
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Markers of Coagulation Plasminogen Activator Inhibitor-1 (ng/mL)
[Time Frame: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment]
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Secondary ID(s)
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HS-2017-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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