NCT03956173

Brief Summary

The investigators hypothesise that following episodes of hypoglycemia, rebound hyperglycemia may result in a prolonged period of increased QTc and, thereby, increased susceptibility to serious cardiac arrhythmias in patients with type - 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 3, 2024

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

October 12, 2018

Last Update Submit

November 28, 2024

Conditions

Diabetes type1HypoglycemiaArrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • QTc prolongation.

    Difference in mean corrected QT interval (QTc) prolongation during hyperglycemia compared to euglycemia both preceded by insulin induced hypoglycemia

    255 minutes

Secondary Outcomes (12)

  • QTd dispersion.

    255 minutes

  • Atrial ectopic beats.

    255 minutes

  • Bradycardia

    255 minutes

  • Ventricular premature beats

    255 minutes

  • Glucagon response

    255 minutes

  • +7 more secondary outcomes

Study Arms (1)

Clamp group

24 patients with type 1 diabetes.

Other: Hypoglycemic combined with either normo or hyperglycemic clamp.

Interventions

Hypoglycemic combined with either normo or hyperglycemic clamp.OTHER

Twenty-four patients with type 1 diabetes has been recruited for a cross-over study including two experimental days, a combined hypo- and hyperglyemic clamp and a combined hypo- and euglycemic clamp, respectively. Patients will be randomised 1:1 to start with either the combined hypo- and hyperglycemic or the hypo- and euglycemic clamp. The hypo- and hyperglycemic or the hypo- and euglycemic clamp are estimated to last 255 minutes. The two clamp days will be separated by at least 30 days.

Clamp group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

24 patients with type 1 diabetes with insulin treatment for ≥ 3 years.

You may qualify if:

  • 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

You may not qualify if:

  • Arrhythmia diagnosed prior to the screening visit
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Metabolic Physiology, SDCC

Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

HypoglycemiaArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tina Vilsbøll, MD, DMSc

    Steno diabetic centre (SDCC)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

May 20, 2019

Study Start

December 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 3, 2024

Record last verified: 2022-07

Locations

DK(1)