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Diabetes Mellitus, Type 2HYPO-HEARTNCT03150030

Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

An observational study of Diabetes Mellitus, Type 2 and Arrhythmia, Cardiac, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one individuals with normal glucose tolerance matched for age, gender, and body mass index. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Combined hyper- and hypoglycaemic clamp, Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) and Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Type of treatment
Medical device
How many people
42 participants
Where
1 siteDenmark
Study dates
1 Feb 2017to 6 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patiens with insulin-treated type 2 diabetes with complications and healthy controls

Who may be able to join

  • Patients with type 2 diabetes
  • Informed and written consent
  • Type 2 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
  • Treatment with insulin
  • Glycated haemoglobin A1c (HbA1c) ≤58 mmol/mol
  • One or more clinical relevant complications to diabetes defined as: peripheral neuropathy with vibration perception threshold of > 25 volt determined by biothesiometry, moderate to severe retinopathy, nephropathy (creatinine >130 μmol/l and/or albuminuria), and/or macrovascular disease. Macrovascular disease is defined as coronary disease (stable angina pectoris or previous unstable angina pectoris or myocardial infarct), cerebrovascular disease (previous stroke or transitional cerebral ischaemia), and peripheral vascular disease (previous intermittent claudication or prior acute ischemia)
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  • Well-functioning LR during run-in period (acceptable readings judged by an arrhythmologist)
  • Participation in the extended study
  • Healthy individuals
  • HbA1c ≤42 mmol/mol
  • Fasting plasma glucose ≤6.1 mmol/l

Who cannot join

  • Patients with type 2 diabetes
  • Arrhythmia diagnosed prior to or at the time of inclusion
  • Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
  • Severe heart failure (left ventricular ejection fraction <25%)
  • Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
  • Insulin naïve patients with type 2 diabetes
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  • Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
  • Unable to comply with daily CGM during run-in period
  • Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)
  • Healthy individuals
  • Type 1 or type 2 diabetes
  • Prediabetes (HbA1c >42 mmol/l and/or fasting plasma glucose >6.1 mmol/l)
  • Family history of diabetes (type 1 og type 2 diabetes)
  • Arrhythmia diagnosed prior to or at the time of inclusion
  • ICD or pacemaker at the time of inclusion
  • Severe heart failure (left ventricular ejection fraction <25%)
  • Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
  • Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
  • Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Gentofte Hospital

    Hellerup, 2900

Other trials in Denmark

About this study

Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one individuals with normal glucose tolerance matched for age, gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week run-in period with LR and CGM prior to participation in Part 1. Only patients with a well-functioning loop-recorder and who can comply with CGM will be included. Patients with type 2 diabetes will continue in part 2 of the study, a one year observational study employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended observation period of 2 years employing LR and clinical examination.

Being tested
Combined hyper- and hypoglycaemic clamp, Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA), Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Medical subject headings
Diabetes Mellitus, Type 2, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined hyper- and hypoglycaemic clampOther

    During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute. Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM). Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study. Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone. A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.

  • Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)Device

    Implantation of a loop-recorder

  • Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)Device

    Monitoring with a continuous glucose monitor

Study groups in NCT03150030
Study groupRoleWhat they receive
Patients with type 2 diabetesInsulin-treated type 2 diabetes with diabetic complications
Receives: Other: Combined hyper- and hypoglycaemic clamp; Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA); Device: Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Healthy controlsHealthy control subjects
Receives: Other: Combined hyper- and hypoglycaemic clamp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Clinically relevant arrhythmias

    Composite endpoint including atrial fibrillation, brady-arrhythmias and tachy-arrhythmias. Clinically relevant brady-arrhythmias are defined as sinus arrest for more than 3 seconds, frequency below 30 beats per minute (bpm), or high grade atrioventricular (AV) block including Mobitz Type II and third-degree AV block. Clinically relevant tachy-arrhythmias are defined as sustained ventricular tachycardia (duration >30 seconds), and non-sustained ventricular tachycardia.

    Measured: 0-240 min during the combined hyper- and hypoglycaemic clamp

  2. Part 2: Prevalence of clinically relevant arrhythmias as defined above

    Prevalence of clinically relevant arrhythmias as defined above

    Measured: Within 12 months

  3. Part 2: Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia

    Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia

    Measured: Within 12 months

  4. Part 2: Difference in MAGE

    Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event

    Measured: Within 12 months

Secondary outcomes (9)

  1. Part 1: Differences in mean corrected QT interval (QTc)

    Differences in mean corrected QT interval (QTc) between patients with type 2 diabetes and matched normal glucose tolerant individuals during the combined hyper- and hypoglycaemic clamp

    Measured: 0-240 min during the combined hyper- and hypoglycaemic clamp

  2. Part 1: Difference in counter regulatory hormonal response

    Difference in counter regulatory hormonal response between patients with type 2 diabetes and matched normal glucose tolerant individuals during the combined hyper- and hypoglycaemic clamp

    Measured: 0-240 min during the combined hyper- and hypoglycaemic clamp

  3. Part 1: Differences in haemodynamic regulation

    Differences in haemodynamic regulation (measured by echocardiography) between patients with type 2 diabetes and matched normal glucose tolerant individuals during a combined hyper- and hypoglycaemic clamp

    Measured: 0-240 min during the combined hyper- and hypoglycaemic clamp

  4. Part 2: Clinical relevant arrhythmias during low glucose variability compared to high glucose variability.

    Clinical relevant arrhythmias during low glucose variability (LGV), defined as variations in plasma glucose below or equal to 5 mmol/l within two hours preceding an arrhythmic event, compared to high glucose variability (HGV), defined as variations in plasma glucose above 5 mmol/l within two hours preceding an arrhythmic event

    Measured: Within 12 months

  5. Part 2: The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    The relationship between cardiovascular disease (heart failure and ischaemic heart disease) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    Measured: Within 12 months

  6. Part 2: The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    Measured: Within 12 months

  7. Part 2: The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    The relationship between diabetes complication status (neuropathy, nephropathy, retinopathy) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV

    Measured: Within 12 months

  8. Part 2: Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias

    Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias

    Measured: Within 12 months

  9. Part 2: Correlation between plasma glucose variation and risk of clinical relevant arrhythmias

    Correlation between plasma glucose variation (variation in plasma glucose (Δ mmol/l) within two hours of the event) and risk of clinical relevant arrhythmias

    Measured: Within 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2017
  2. Study start1 Feb 2017
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150030
Sponsor's protocol ID
H-16046212
Acronym
HYPO-HEART
Status last verified
Oct 2020
First submitted
25 Apr 2017
Last updated
2 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Andersen A, Bagger JI, Sorensen SK, Baldassarre MPA, Pedersen-Bjergaard U, Forman JL, Gislason G, Lindhardt TB, Knop FK, Vilsboll T. Associations of hypoglycemia, glycemic variability and risk of cardiac arrhythmias in insulin-treated patients with type 2 diabetes: a prospective, observational study. Cardiovasc Diabetol. 2021 Dec 24;20(1):241. doi: 10.1186/s12933-021-01425-0.

    PubMed 34952579

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Arrhythmia, Cardiac, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

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 11 inclusion and 19 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 2 Nov 2020. 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part 1: Clinically relevant arrhythmias (time frame: 0-240 min during the combined hyper- and hypoglycaemic clamp). The study lists 4 primary outcomes in all. 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 NCT03150030, 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 2 Nov 2020.

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