NCT03386864

Brief Summary

Assessment of cardiac energy metabolism in patients with impaired glucose tolerance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 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

April 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

May 29, 2017

Last Update Submit

August 4, 2023

Conditions

Heart FailureDiabetes Mellitus

Keywords

Heart Failure, Diabetes Mellitus, Mitochondrial Respiration

Outcome Measures

Primary Outcomes (1)

  • mitochondrial oxygen flux

    measured using high resolution respirometry. Unit: pmol/(s\*mg)

    Up to 36 months

Study Arms (3)

Control

Control

Insulin Resistant

Insulin Resistant

Type 2 Diabetes

Type 2 Diabetes

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing myocardial biopsy, left ventricular assist device implantation or heart transplantation for medical reasons

You may qualify if:

  • age ≥ 20 and ≤85 years
  • myocardial biopsy for medical reason

You may not qualify if:

  • acute infection
  • autoimmune disease
  • pregnancy
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40223, Germany

Location

Related Publications (2)

  • Zweck E, Scheiber D, Jelenik T, Bonner F, Horn P, Pesta D, Schultheiss HP, Boeken U, Akhyari P, Lichtenberg A, Kelm M, Roden M, Westenfeld R, Szendroedi J. Exposure to Type 2 Diabetes Provokes Mitochondrial Impairment in Apparently Healthy Human Hearts. Diabetes Care. 2021 May;44(5):e82-e84. doi: 10.2337/dc20-2255. No abstract available.

    PMID: 33972315DERIVED

  • Jelenik T, Flogel U, Alvarez-Hernandez E, Scheiber D, Zweck E, Ding Z, Rothe M, Mastrototaro L, Kohlhaas V, Kotzka J, Knebel B, Muller-Wieland D, Moellendorf S, Godecke A, Kelm M, Westenfeld R, Roden M, Szendroedi J. Insulin Resistance and Vulnerability to Cardiac Ischemia. Diabetes. 2018 Dec;67(12):2695-2702. doi: 10.2337/db18-0449. Epub 2018 Sep 26.

    PMID: 30257974DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Myocardial biopsies blood samples

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julia Szendroedi, Prof., MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

December 29, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)