NCT02684331

Brief Summary

The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires. This study project sets out to answer the following hypotheses:

  1. 1.Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.
  2. 2.Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

February 8, 2016

Last Update Submit

September 18, 2019

Conditions

Diabetes Mellitus, Type 2Heart Disease

Outcome Measures

Primary Outcomes (3)

  • On CMR; left ventricle peak filling rate (ml/s)

    Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

    Cross-sectional so at baseline

  • On CMR, LV myocardial perfusion

    Including measurements at rest and with Adenosin stress

    Cross-sectional so at baseline

  • On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function

    Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

    Cross-sectional so at baseline

Secondary Outcomes (3)

  • Echocardiography

    Cross-sectional so at baseline

  • Blod samples

    Cross-sectional so at baseline

  • Echocardiography

    Cross-sectional so at baseline

Study Arms (1)

T2DM

Other: Cardiac Magnetic Resonance Imaging (CMR)Other: EchocardiographyOther: Bood samples

Interventions

Cardiac Magnetic Resonance Imaging (CMR)OTHER

An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.

T2DM
EchocardiographyOTHER

Standard measurements and strain.

T2DM
Bood samplesOTHER

HbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3

T2DM

Eligibility Criteria

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

300 T2DM patients, with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will be divided into groups depending on their diabetes complication status. Individual groups of patients with fx. +/- retinopathy, +/- autonomous neuropathy, +/- hypertension, normo-/mikro-/makroalbuminuria will be compared.

You may qualify if:

  • Male or female patient fully capable of informed consent
  • Informed consent
  • T2DM
  • Age 18-80 (both years included)

You may not qualify if:

  • Contraindications to CMR (pacemakers/ICD-units, cochlear implants)
  • Lack of consent
  • Atrial fibrillation
  • Women of childbearing potential who are not on acceptable contraception
  • Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations)
  • Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure
  • Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The diabetes outpatient clinic, Slagelse Hospital, Denmark

Slagelse, 4200, Denmark

Location

Related Publications (5)

  • Bojer AS, Sorensen MH, Madsen SH, Broadbent DA, Plein S, Gaede P, Madsen PL. The independent association of myocardial extracellular volume and myocardial blood flow with cardiac diastolic function in patients with type 2 diabetes: a prospective cross-sectional cohort study. Cardiovasc Diabetol. 2023 Mar 31;22(1):78. doi: 10.1186/s12933-023-01804-9.

    PMID: 37004049DERIVED

  • Bojer AS, Sorensen MH, Vejlstrup N, Goetze JP, Gaede P, Madsen PL. Distinct non-ischemic myocardial late gadolinium enhancement lesions in patients with type 2 diabetes. Cardiovasc Diabetol. 2020 Oct 22;19(1):184. doi: 10.1186/s12933-020-01160-y.

    PMID: 33092588DERIVED

  • Sorensen MH, Bojer AS, Jorgensen NR, Broadbent DA, Plein S, Madsen PL, Gaede P. Fibroblast growth factor-23 is associated with imaging markers of diabetic cardiomyopathy and anti-diabetic therapeutics. Cardiovasc Diabetol. 2020 Sep 30;19(1):158. doi: 10.1186/s12933-020-01135-z.

    PMID: 32998751DERIVED

  • Sorensen MH, Bojer AS, Pontoppidan JRN, Broadbent DA, Plein S, Madsen PL, Gaede P. Reduced Myocardial Perfusion Reserve in Type 2 Diabetes Is Caused by Increased Perfusion at Rest and Decreased Maximal Perfusion During Stress. Diabetes Care. 2020 Jun;43(6):1285-1292. doi: 10.2337/dc19-2172. Epub 2020 Mar 19.

    PMID: 32193248DERIVED

  • Sorensen MH, Bojer AS, Broadbent DA, Plein S, Madsen PL, Gaede P. Cardiac perfusion, structure, and function in type 2 diabetes mellitus with and without diabetic complications. Eur Heart J Cardiovasc Imaging. 2020 Aug 1;21(8):887-895. doi: 10.1093/ehjci/jez266.

    PMID: 31642902DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-plasma Heparin-plasma Serum urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Officials

  • Martin H Soerensen, DM

    Slagelse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 18, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)