DiabetesNCT05500352
Acute Changes in Plasma Glucose and Cardiovascular Disease in Diabetes
A study testing Hyperglycemia with slow decline in plasma glucose in type 1 diabetes, Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes and Rebound hyperglycemia in type 1 diabetes in people with Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Patients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypoglycemia, Hyperglycemia
- What is being tested?
- Hyperglycemia with slow decline in plasma glucose in type 1 diabetes, Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes and Rebound hyperglycemia in type 1 diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2022to 1 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Informed and written consent
- Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- Age 18-70 years
- Insulin treatment for ≥3 years
- Informed and written consent
- Type 2 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
Show all 22Show fewer
- Treatment with insulin
- Glycated haemoglobin A1c (HbA1c) ≤58 mmol/mol
- HbA1c ≤42 mmol/mol
- Fasting plasma glucose ≤6.1 mmol/l
- Informed and written consent
- Type 1 diabetes
- Age ≥18 years
- C-peptide negative (<0.2 nmol/l)
- Insulin treatment for ≥1 year
- HbA1C ≥63 mmol/mol
- Informed and written consent
- Type 1 diabetes
- Age ≥18 years
- C-peptide negative (<0.2nmol/l)
- Insulin treatment for ≥1 year
- HbA1C ≤53 mmol/mol
Who cannot join
- Arrhythmia diagnosed prior to the screening visit
- 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)
- Thyroid dysfunction (except for well-regulated eltroxin substituted myxoedema)
- Anemia (male: hemoglobin <8.0; female: hemoglobin <7.0 mmol/l)
Show all 34Show fewer
- Hypo-Heart 2:
- 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
- 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)
- 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)
- Rapid-Heart:
- Arrhythmia diagnosed prior to or at the time of the screening visit
- ECG with left or right bundle branch block diagnosed prior to the screening visit.
- Implantable cardioverter defibrillator or pacemaker at the time of inclusion
- Heart failure diagnosed prior to the screening visit (left ventricular ejection fraction < 45%)
- Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- Thyroid dysfunction (except for well-regulated myxoedema)
- Anaemia (male: haemoglobin <8.0 mmol/l; female: haemoglobin <7.0 mmol/l)
- Treatment with anticoagulant or antiplatelet treatment
- Bleeding disorder diagnosed prior to the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Work and Left Ventricular Mechanical Dyssynchrony During Acute Changes in Plasma Glucose in Individuals With Type 1 Diabetes, Type 2 Diabetes and Without Diabetes
Patients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is associated with macrovascular complications and increased mortality. The physiological mechanisms linking hypoglycemia and glycemic variability to CVD and CV events remain unclear.
Myocardial work and mechanical dyssynchrony will be measured by speckle tracking echocardiography during euglycemia, hypoglycemia and hyperglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes. Echocardiographic images from three experimental clamp studies - Hypo-Heart 1 (sub-study 1), Hypo-Heart 2 (sub-study 2) and Rapid-Heart - will be included in this study.
Read the detailed description
The results of this study may be compiled into one or more manuscripts for publication.
Study ID's:
Hypo-Heart 1 (sub-study 1): NCT03956173 Hypo-Heart 2 (sub-study 2): NCT03150030 Rapid-Heart: NCT04800536
- Being tested
- Hyperglycemia with slow decline in plasma glucose in type 1 diabetes, Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes, Rebound hyperglycemia in type 1 diabetes, Rebound euglycemia in type 1 diabetes, Hypoglycemia in type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Hyperglycemia, Cardiovascular Diseases, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycemia with slow decline in plasma glucose in type 1 diabetesOther
Acute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Slow plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l).
Hyperglycemia with rapid decline in plasma glucose in type 1 diabetesOther
Acute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Rapid plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l).
Rebound hyperglycemia in type 1 diabetesOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in hyperglycemia (20.0 mmol/L)
Rebound euglycemia in type 1 diabetesOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in euglycemia (PG: 5-8 mmol/L).
Hypoglycemia in type 1 diabetesOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in hyperglycemia (20.0 mmol/L) or euglycemia (PG: 5-8 mmol/L)
Hypoglycemia in type 2 diabetesOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L).
Hypoglycemia in healthy controlsOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L).
Hyperglycemia in type 2 diabetesOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L).
Hyperglycemia in healthy controlsOther
Also called Experimental clamp
Includes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L).
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular effects of slowly declining plasma glucose in type 1 diabetes | Experimental | Not described Receives: Other: Hyperglycemia with slow decline in plasma glucose in type 1 diabetes |
| Cardiovascular effects of rapidly declining plasma glucose in type 1 diabetes | Experimental | Not described Receives: Other: Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes |
| Cardiovascular effects of rebound hyperglycemia in type 1 diabetes | Experimental | Not described Receives: Other: Rebound hyperglycemia in type 1 diabetes |
| Cardiovascular effects of rebound euglycemia in type 1 diabetes | Experimental | Not described Receives: Other: Rebound euglycemia in type 1 diabetes |
| Cardiovascular effects of hypoglycemia in type 1 diabetes | Experimental | Not described Receives: Other: Hypoglycemia in type 1 diabetes |
| Cardiovascular effects of hypoglycemia in type 2 diabetes | Experimental | Not described Receives: Other: Hypoglycemia in type 2 diabetes |
| Cardiovascular effects of hypoglycemia in healthy controls | Experimental | Not described Receives: Other: Hypoglycemia in healthy controls |
| Cardiovascular effects of hyperglycemia in type 2 diabetes | Experimental | Not described Receives: Other: Hyperglycemia in type 2 diabetes |
| Cardiovascular effects of hyperglycemia in healthy controls | Experimental | Not described Receives: Other: Hyperglycemia in healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
Absolute change in the global work index measured by pressure-strain loop analysis during insulin-induced hypoglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively (Hypo-Heart 1 and Hypo-Heart 2).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)
Secondary outcomes (5)
Primary secondary outcome: Change in mechanical dyssynchrony during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
Absolute change in mechanical dyssynchrony (defined as the standard deviation of regional time to peak strain) measured by speckle tracking echocardiography measured by pressure-strain loop analysis during insulin-induced hypoglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively (Hypo-Heart 1 and Hypo-Heart 2).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)
Change in the global work during recovery in individuals with type 1 diabetes.
Absolute change in the global work index measured by pressure-strain loop analysis during recovery (post-hypoglycemic euglycemia and hyperglycemia) compared to euglycemia in individuals with type 1 diabetes (Hypo-Heart 1).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes
Change in mechanical dyssynchrony during recovery in individuals with type 1 diabetes.
Absolute change in mechanical dyssynchrony (defined as the standard deviation of regional time to peak strain) measured by speckle tracking echocardiography measured by pressure-strain loop analysis during recovery (post-hypoglycemic euglycemia and hyperglycemia) compared to euglycemia in individuals with type 1 diabetes (Hypo-Heart 1).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes
Change in the global work during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.
Absolute change in the global work index measured by pressure-strain loop analysis during hyperglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively (Rapid Heart and Hypo-Heart 2).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2)
Change in mechanical dyssynchrony during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.
Absolute change in mechanical dyssynchrony (defined as the standard deviation of regional time to peak strain) measured by speckle tracking echocardiography measured by pressure-strain loop analysis during hyperglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively (Rapid Heart and Hypo-Heart 2).
Study outcomes will be analyzed separately for each included study.
Measured: 255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Jul 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- The present echocardiographic study includes participants from three experimental clamp studies; the Hypo-Heart 1 (Study 1), Hypo-Heart 2 (Study 2) and Rapid-Heart (Study 3).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tina Vilsbøll, Principal investigator, Steno Diabetes Center Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500352
- Sponsor's protocol ID
- H18034040_part2
- Status last verified
- Aug 2022
- First submitted
- 6 Jul 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Work and Left Ventricular Mechanical Dyssynchrony During Acute Changes in Plasma Glucose in Individuals With Type 1 Diabetes, Type 2 Diabetes and Without Diabetes
- ClinicalTrials.gov ID
- NCT05500352
- Acronym / sponsor ID
- H18034040_part2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is associated with macrovascular complications and increased mortality. The physiological mechanisms linking hypoglycemia and glycemic variability to CVD and CV events remain unclear.
Myocardial work and mechanical dyssynchrony will be measured by speckle tracking echocardiography during euglycemia, hypoglycemia and hyperglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes. Echocardiographic images from three experimental clamp studies - Hypo-Heart 1 (sub-study 1), Hypo-Heart 2 (sub-study 2) and Rapid-Heart - will be included in this study.
Detailed description
The results of this study may be compiled into one or more manuscripts for publication.
Study ID's:
Hypo-Heart 1 (sub-study 1): NCT03956173 Hypo-Heart 2 (sub-study 2): NCT03150030 Rapid-Heart: NCT04800536
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 9
- Model description
- The present echocardiographic study includes participants from three experimental clamp studies; the Hypo-Heart 1 (Study 1), Hypo-Heart 2 (Study 2) and Rapid-Heart (Study 3).
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular effects of slowly declining plasma glucose in type 1 diabetes | Experimental | Other: Hyperglycemia with slow decline in plasma glucose in type 1 diabetes |
| Cardiovascular effects of rapidly declining plasma glucose in type 1 diabetes | Experimental | Other: Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes |
| Cardiovascular effects of rebound hyperglycemia in type 1 diabetes | Experimental | Other: Rebound hyperglycemia in type 1 diabetes |
| Cardiovascular effects of rebound euglycemia in type 1 diabetes | Experimental | Other: Rebound euglycemia in type 1 diabetes |
| Cardiovascular effects of hypoglycemia in type 1 diabetes | Experimental | Other: Hypoglycemia in type 1 diabetes |
| Cardiovascular effects of hypoglycemia in type 2 diabetes | Experimental | Other: Hypoglycemia in type 2 diabetes |
| Cardiovascular effects of hypoglycemia in healthy controls | Experimental | Other: Hypoglycemia in healthy controls |
| Cardiovascular effects of hyperglycemia in type 2 diabetes | Experimental | Other: Hyperglycemia in type 2 diabetes |
| Cardiovascular effects of hyperglycemia in healthy controls | Experimental | Other: Hyperglycemia in healthy controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Informed and written consent
- Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- Age 18-70 years
- Insulin treatment for ≥3 years
- Informed and written consent
Key exclusion criteria (34 listed)
- Arrhythmia diagnosed prior to the screening visit
- 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)
- Thyroid dysfunction (except for well-regulated eltroxin substituted myxoedema)
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 |
|---|---|---|
| Hyperglycemia with slow decline in plasma glucose in type 1 diabetesAcute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Slow plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l). | Other | Cardiovascular effects of slowly declining plasma glucose in type 1 diabetes |
| Hyperglycemia with rapid decline in plasma glucose in type 1 diabetesAcute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Rapid plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l). | Other | Cardiovascular effects of rapidly declining plasma glucose in type 1 diabetes |
| Rebound hyperglycemia in type 1 diabetesAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in hyperglycemia (20.0 mmol/L) | Other | Cardiovascular effects of rebound hyperglycemia in type 1 diabetes |
| Rebound euglycemia in type 1 diabetesAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in euglycemia (PG: 5-8 mmol/L). | Other | Cardiovascular effects of rebound euglycemia in type 1 diabetes |
| Hypoglycemia in type 1 diabetesAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (5-8 mmol/L), 2) hyperinsulinemic hypoglycemic phase (PG: 2.5 mmol/L), 3) recovery phase in hyperglycemia (20.0 mmol/L) or euglycemia (PG: 5-8 mmol/L) | Other | Cardiovascular effects of hypoglycemia in type 1 diabetes |
| Hypoglycemia in type 2 diabetesAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L). | Other | Cardiovascular effects of hypoglycemia in type 2 diabetes |
| Hypoglycemia in healthy controlsAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L). | Other | Cardiovascular effects of hypoglycemia in healthy controls |
| Hyperglycemia in type 2 diabetesAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L). | Other | Cardiovascular effects of hyperglycemia in type 2 diabetes |
| Hyperglycemia in healthy controlsAlso: Experimental clampIncludes three steady state phases in plasma glucose, 1) euglycemic phase (fasting PG), 2) hyperglycemic phase (fasting PG + 10 mmol/L), 3) hyperinsulinemic hypoglycemic phase (PG < 3.0 mmol/L). | Other | Cardiovascular effects of hyperglycemia in healthy controls |
Primary outcome
Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
Time frame: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)
Absolute change in the global work index measured by pressure-strain loop analysis during insulin-induced hypoglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively (Hypo-Heart 1 and Hypo-Heart 2). Study outcomes will be analyzed separately for each included study.
5 secondary outcomes
Primary secondary outcome: Change in mechanical dyssynchrony during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
Time frame: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)
Change in the global work during recovery in individuals with type 1 diabetes.
Time frame: 255 minutes
Change in mechanical dyssynchrony during recovery in individuals with type 1 diabetes.
Time frame: 255 minutes
Change in the global work during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.
Time frame: 255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2)
Change in mechanical dyssynchrony during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.
Time frame: 255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
Tina Vilsbøll principal investigator
Steno Diabetes Center Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperglycemia with slow decline in plasma glucose in type 1 diabetes, Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes and Rebound hyperglycemia in type 1 diabetes in people with Diabetes and Hypoglycemia, run by Steno Diabetes Center 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 22 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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?
Results are not available in the source record.
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?
Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively. (time frame: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.