NCT03022344

Brief Summary

However, there is only very sparse information regarding the atherosclerotic burden and cardiovascular biomarkers in the early stages of type-2 diabetes, as the vast majority of studies have concerned diabetes populations with more than 5 years average diabetes age or high-risk subgroups, who at inclusion already had atherosclerotic disease manifestations. Consequently, this study aims on evaluating the occurrence of early-stage subclinical atherosclerosis in newly diagnosed type-2 diabetes with special emphasis on coronary plaque characteristics by modern imaging techniques. These findings will be compared to the functional status of various peripheral arterial segments and biomarkers in the cross-sectional part of this study. The 5-year follow-up study intends to describe relationships between these selected measures for general atherosclerotic involvement and the progression of the coronary atherosclerotic burden by contemporary techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

6.6 years

First QC Date

January 9, 2017

Last Update Submit

May 6, 2018

Conditions

DiabetesPlaqueAtherosclerosis

Keywords

DD2 plaque studyCoronary plaqueType-2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Progression of contrast enhanced cardiac CT in relation to baseline and follow-up cardiovascular risk factors and biomarkers.

    Coronary artery calcification were quantified by non-contrast cardiac CT and were assessed by summing up the scores from all foci in the coronary arteries, expressed in Agatston units (U), using dedicated software (Syngo Calcium scoring, (Siemens Healthcare).

    5 years

Secondary Outcomes (6)

  • Biochemical analysis in relation to contrast enhanced cardiac CT

    1 year

  • Body mass index (kg/m2)

    1 year

  • Carotid intima media thickness

    1 year

  • Ankle brachial index

    1year

  • waist hip ratio (m)

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Healthy

SHAM COMPARATOR

Patients in this cohort consist of 100 healthy patients

Radiation: Cardiac CT

Diabetes mellitus

SHAM COMPARATOR

Newly diagnosed (\< 1 year) diabetes patients clinically classified as type-2 diabetes patients of both sex

Radiation: Cardiac CT

Interventions

Cardiac CTRADIATION
Diabetes mellitusHealthy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed (\< 1 year) diabetes patients clinically classified as type-2 diabetes patients of both sex.
  • Age 18 +.

You may not qualify if:

  • Type 1 diabetes (or have age\<30 years and C-peptid\<300pmol/l and GAD-ab titer\> 20 IU/ml).
  • Renal insufficiency (GFR \< 45 or se-creatinine \>140 micromol/l).
  • BMI \> 35.
  • Atrial fibrillation.
  • Life expectancy below 2 years.
  • Mental disease and/or misuse of alcohol or drugs that affects patient's ability to give informed consent.
  • Patients with a history of prior atherothrombotic disease (including acute coronary syndromes, prior revascularization, ischemic stroke or peripheral arterial disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydvestjysk sygehus

Esbjerg, DK-6700, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusPlaque, AmyloidAtherosclerosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 16, 2017

Study Start

November 1, 2014

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)