Diabetes Mellitus With HypoglycemiaDiaplateNCT03460899
Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
A study testing Euglycaemic Clamp and Hyperinsulinaemic/Hypoglycaemic Clamp in people with Diabetes Mellitus With Hypoglycemia and Diabetes Mellitus, Type 2, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus With Hypoglycemia, Diabetes Mellitus, Type 2, Hypoglycemia
- What is being tested?
- Euglycaemic Clamp and Hyperinsulinaemic/Hypoglycaemic Clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 12 Feb 2018to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department for Internal Medicine
Graz, 8036
About this study
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.
Read the detailed description
Increased platelet activation is significantly involved in the pathophysiology of micro- and macrovascular diabetic complications. Previously performed studies suggested platelet activation in both, hyper- and hypoglycaemic states, leading to a potentially increased risk for thromboembolic complications. Hypoglycaemia, in particular severe hypoglycaemic episodes, has been associated with increased cardiovascular or overall mortality in previous studies. Potential mechanisms include arrhythmias or increased risk for thromboembolism, based on platelet activation and/or hypercoagulability.
The aim of this experimental study is to investigate the impact of hypoglycaemia on platelet activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. We hypothesize that Hypoglycaemia in patients with T2DM leads to increased platelet activation.
The primary objective is to investigate platelet activation during different levels of hypoglycaemia induced by a stepwise hyperinsulinaemic, hypoglycemic clamp experiment in patients with T2DM.
Active study duration will be 5 days for each study participant. 14 subjects with T2DM without history of cardiovascular events or manifest atherosclerosis will be enrolled. During this monocentric, single arm, open, mechanistic trial platelet activation and recovery at one week after the clamp experiment, changes of pro-atherothrombotic markers during the hypoglycaemic clamp as well as counter regulatory hormone response during the clamp will be investigated.
- Conditions
- Diabetes Mellitus With Hypoglycemia, Diabetes Mellitus, Type 2, Hypoglycemia, Hypoglycemic Episode
- Being tested
- Euglycaemic Clamp, Hyperinsulinaemic/Hypoglycaemic Clamp
- Keywords
- Hypoglycaemia, Platelet activity, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euglycaemic ClampOther
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)
Hyperinsulinaemic/Hypoglycaemic ClampOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Clamp Arm | Experimental | All 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insulin (Actrapid) will be used to reach certain plasma glucose levels. Receives: Other: Euglycaemic Clamp; Other: Hyperinsulinaemic/Hypoglycaemic Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Platelet Activation Marker Adenosin Diphosphate (%)
Changes in platelet activation measured by light transmittance aggregometry (LTA) on a Chronolog 700 Lumi-Aggregometer based on Adenosin Diphosphate (ADP %) activation.
Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:
Timepoint 0 (Baseline = Plasma Glucose 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = Plasma Glucose 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = Plasma Glucose 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = Plasma Glucose 100mg/dL [5.5mmol/L]
Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)
Measured: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment
Secondary outcomes (3)
Quantification of Platelet Function and Activation PAC1CD62PCD63POS (%)
Quantification of platelet activation markers by flow cytometry in unstimulated blood samples (CD62P, CD63 and binding of PAC-1) using a BD LSRFortessa flow cytometer.
Hyperinsulinaemic/Hypoglycaemic clamp Experiment:
Timepoint 0 (Baseline = Plasma Glucose 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = Plasma Glucose 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = Plasma Glucose 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = Plasma Glucose 100mg/dL [5.5mmol/L]
Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)
Measured: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment
Markers of Coagulation Plasminogen Activator Inhibitor-1 (ng/mL)
Effects on coagulation parameter plasminogen activator Inhibitor-1 (PAI-1) measured by Enzyme-linked immunosorbent assays.
Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:
Timepoint 0 (Baseline = PG 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = PG 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = PG 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = PG 100mg/dL [5.5mmol/L]
Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)
Measured: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment
Changes in Coagulation Marker Fibrinogen (g/L)
Changes in coagulation marker Fibrinogen, measured on a Behring Coagulation System BCS XP Analyzer.
Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:
Timepoint 0 (Baseline = PG 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = PG 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = PG 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = PG 100mg/dL [5.5mmol/L]
Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)
Measured: Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start12 Feb 2018
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Harald Sourij, Principal investigator, Medical University of Graz, Division of Endocrinology and Diabetology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460899
- Sponsor's protocol ID
- HS-2017-04
- Acronym
- Diaplate
- Status last verified
- Nov 2019
- First submitted
- 22 Feb 2018
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eyileten C, Wicik Z, Keshwani D, Aziz F, Aberer F, Pferschy PN, Tripolt NJ, Sourij C, Prietl B, Pruller F, von Lewinski D, De Rosa S, Siller-Matula JM, Postula M, Sourij H. Alteration of circulating platelet-related and diabetes-related microRNAs in individuals with type 2 diabetes mellitus: a stepwise hypoglycaemic clamp study. Cardiovasc Diabetol. 2022 May 20;21(1):79. doi: 10.1186/s12933-022-01517-5.
PubMed 35596173
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
- ClinicalTrials.gov ID
- NCT03460899
- Acronym / sponsor ID
- Diaplate / HS-2017-04
- Conditions
- Diabetes Mellitus With Hypoglycemia, Diabetes Mellitus, Type 2, Hypoglycemia, Hypoglycemic Episode
- Keywords
- Hypoglycaemia, Platelet activity, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Increased platelet activation is significantly involved in the pathophysiology of micro- and macrovascular diabetic complications. Previously performed studies suggested platelet activation in both, hyper- and hypoglycaemic states, leading to a potentially increased risk for thromboembolic complications. Hypoglycaemia, in particular severe hypoglycaemic episodes, has been associated with increased cardiovascular or overall mortality in previous studies. Potential mechanisms include arrhythmias or increased risk for thromboembolism, based on platelet activation and/or hypercoagulability.
The aim of this experimental study is to investigate the impact of hypoglycaemia on platelet activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. We hypothesize that Hypoglycaemia in patients with T2DM leads to increased platelet activation.
The primary objective is to investigate platelet activation during different levels of hypoglycaemia induced by a stepwise hyperinsulinaemic, hypoglycemic clamp experiment in patients with T2DM.
Active study duration will be 5 days for each study participant. 14 subjects with T2DM without history of cardiovascular events or manifest atherosclerosis will be enrolled. During this monocentric, single arm, open, mechanistic trial platelet activation and recovery at one week after the clamp experiment, changes of pro-atherothrombotic markers during the hypoglycaemic clamp as well as counter regulatory hormone response during the clamp will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clamp Arm | Experimental | Other: Euglycaemic Clamp, Other: Hyperinsulinaemic/Hypoglycaemic ClampAll 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insulin (Actrapid) will be used to reach certain plasma glucose levels. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Euglycaemic ClampAll 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 | Clamp Arm |
| Hyperinsulinaemic/Hypoglycaemic ClampAll 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) | Other | Clamp Arm |
Primary outcome
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
Changes in platelet activation measured by light transmittance aggregometry (LTA) on a Chronolog 700 Lumi-Aggregometer based on Adenosin Diphosphate (ADP %) activation. Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment: Timepoint 0 (Baseline = Plasma Glucose 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = Plasma Glucose 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = Plasma Glucose 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = Plasma Glucose 100mg/dL [5.5mmol/L] Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35596173Eyileten C, Wicik Z, Keshwani D, Aziz F, Aberer F, Pferschy PN, Tripolt NJ, Sourij C, Prietl B, Pruller F, von Lewinski D, De Rosa S, Siller-Matula JM, Postula M, Sourij H. Alteration of circulating platelet-related and diabetes-related microRNAs in individuals with type 2 diabetes mellitus: a stepwise hypoglycaemic clamp study. Cardiovasc Diabetol. 2022 May 20;21(1):79. doi: 10.1186/s12933-022-01517-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Sourij principal investigator
Medical University of Graz, Division of Endocrinology and Diabetology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euglycaemic Clamp and Hyperinsulinaemic/Hypoglycaemic Clamp in people with Diabetes Mellitus With Hypoglycemia and Diabetes Mellitus, Type 2, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.