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NCT Number: NCT04650646

Cardiovascular Effects of Exercise-related Hypoglycaemia in Patients With Type 1 Diabetes (Hypo Heart Exercise)

Patients with type 1 diabetes are recommended to perform at least 150 minutes of accumulated physical activity each week, however fear of hypoglycaemia is a well-known barrier to exercise in these patients. Previous experimental studies have almost exclusively focused on investigating cardiovascular effects of hypoglycaemia under resting conditions, however other underlying circumstances prior to or during a hypoglycaemic event, (e.g. exercise) are rarely discussed in the literature but might, nevertheless, be of significant clinical importance.

In this study, the investigators aim to investigate the QT interval dynamics and prothrombotic factors during exercise-related hypoglycaemia in comparison with hypoglycaemia under resting conditions, in patients with type 1 diabetes.

Fifteen patients with type 1 diabetes will be recruited for a crossover study including two test days, a combined euglycaemic- hypoglycaemic clamp combined with an exercise session and an euglycaemic- hypoglycaemic clamp during bed rest, respectively. Furthermore, the participants will be schedueled for a 24-hours followup visit after each test day for the purpose of investigating prolonged prothrombotic effects of hypoglycaemia. Patients will be randomised 1:1 to start with the combined exercise-clamp or the resting-clamp. The two test days will be separated by at least 4 weeks to minimise carry-over effects. A group of fifteen healthy individuals with normal glucose tolerance matched for age, gender and body mass index, will be recruited for a single blood test aiming to compare baseline coagulation status with patients with type 1 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 1 Arrhythmia Arrhythmias, Cardiac Autoimmune Diseases Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research, Steno Diabetes Center Copenhagen-Gentofte

Copenhagen, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed and written consent
  • Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
  • Age ≥ 18 years
  • Insulin treatment for ≥1 year

Exclusion criteria

  • Arrhythmia diagnosed prior to the screening visit.
  • Ischaemic heart disease or myocardial infarction diagnosed prior to the screening visit.
  • Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
  • Heart failure (left ventricular ejection fraction <45%) diagnosed prior to the screening visit.
  • Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
  • ECG with left or right bundle branch block diagnosed prior to the screening visit.
  • Thyroid dysfunction (except for well-regulated levothyroxine-substituted myxoedema)
  • Anaemia (male: haemoglobin <8.0; female: haemoglobin <7.0 mmol/l)
  • Treatment with anticoagulant or antiplatelet treatment.
  • Bleeding disorder diagnosed prior to the screening visit.

Withdrawal criteria

  • The participants may withdraw at will at any time

Treatment and study plan

Exercise-related hypoglycaemia

Other

Hypoglycaemia induced by intravenous insulin and exercise on a vertical cycle ergometer.

Hypoglycaemia under resting conditions

Other

Hypoglycaemia induced by intravenous insulin during bed rest.

Primary outcomes

  1. Hypoglycaemia and QTc interval prolongation

    Time frame: 0-180minutes

    Mean QTc interval prolongation from baseline during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

Secondary outcomes

  1. Key secondary outcome: Hypoglycaemia and coagulation and fibrinolysis

    Time frame: 0-24hours

    Differences in whole blood coagulability and fibrinolysis (measured by thrombelastography) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  2. Hypoglycaemia and QT dispersion (QTd)

    Time frame: 0-180minutes

    Differences in QTd, during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions

  3. Hypoglycaemia and heart rate variability (HRV)

    Time frame: 0-180minutes

    Changes in sympathetic/parasympathetic balance (measured by HRV) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  4. Hypoglycaemia and bradycardia

    Time frame: 0-180minutes

    Differences in non-clinically significant bradycardia (≤45 bpm for 5 seconds) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  5. Hypoglycaemia and ectopic beats

    Time frame: 0-180minutes

    Differences in number of atrial ectopic beats (prematurity threshold 30%) and ventricular premature beats respectively, during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  6. Hypoglycaemia and endothelial activation and damage

    Time frame: 0-24hours

    Differences in plasma markers of endothelial activation and damage (ng/ml) (including Syndecan-1, Soluble thrombomodulin and PECAM-1) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  7. Hypoglycaemia and vascular oxidative stress

    Time frame: 0-24hours

    Differences in markers of vascular oxidative stress (tetrahydrobiopterin/dihydrobiopterin ratio, dehydroascorbic acid/ascorbic acid ratio, asymmetric dimethylarginine/arginine ratio, malondialdehyde) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  8. Hypoglycaemia and electrolytes

    Time frame: 0-180minutes

    Differences in electrolyte concentrations including potassium and ionised calcium during exercise-related hypoglycaemia compared insulin-induced hypoglycaemia under resting conditions.

  9. Hypoglycaemia and counterregulatory hormonal response

    Time frame: 0-180minutes

    Differences in hormonal response (plasma glucagon, cortisol, catecholamines and growth hormone) during exercise-related hypoglycaemia compared insulin-induced hypoglycaemia under resting conditions.

  10. Hypoglycaemia and markers of inflammation

    Time frame: 0-24hours

    Differences in inflammatory response (including interleukin 6 and TNFα) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  11. Hypoglycaemia and inflammation

    Time frame: 0-24hours

    Differences in High-sensitive C-reactive peptide (HsCRP) during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.

  12. Hypoglycaemia and continuous glucose monitoring (CGM) accuracy

    Time frame: 0-180min

    Differences in mean absolute relative difference (MARD) between Dexcom G6®, Abbot Flash Libre® and Yellow Springs Instrument (YSI) reference throughout both experimental days.

  13. Type 1 diabetes, healthy controls and coagulability

    Time frame: 0minutes

    Differences in whole blood coagulability and fibrinolysis (measured by thrombelastography) between patients with type 1 diabetes and healthy control subjects.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Cardiovascular Effects of Exercise-related Hypoglycaemia in Patients With Type 1 Diabetes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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