The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients
1 other identifier
interventional
39
0 countries
N/A
Brief Summary
The overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. Furthermore we will examine the ability of ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. To increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Typical duration for not_applicable
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
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 8, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJune 7, 2019
October 1, 2018
2.2 years
December 8, 2016
June 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mitochondrial respiration of individual complexes
Mitochondrial respiration of individual complexes will serve as primary outcome and will be examined by oxygraph technique.
Outcome will be assessed within a year when the inclusion of patients is complete
Secondary Outcomes (1)
Hemodynamic performance
Outcome will be assessed within a year when the inclusion of patients is complete
Study Arms (8)
non-diabetic Sham control
EXPERIMENTALHeart tissue obtained from non-diabetic patients undergoing surgery will not receive drugs or ischemia
non-diabetic Ischemia reperfusion
EXPERIMENTALHeart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive ischemia
non-diabetic Ischemic preconditioning
EXPERIMENTALHeart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia
non-diabetic Dimethyl malonate
EXPERIMENTALHeart tissue from non-diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia
Diabetic Sham control
EXPERIMENTALHeart tissue obtained from diabetic patients undergoing surgery will not receive drugs or ischemia
Diabetic Ischemia reperfusion
EXPERIMENTALHeart tissue from diabetic patients undergoing surgery will not receive drugs but will receive ischemia
Diabetic Ischemic preconditioning
EXPERIMENTALHeart tissue from diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia
Diabetic Dimethyl malonate
EXPERIMENTALHeart tissue from diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia
Interventions
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Eligibility Criteria
You may qualify if:
- Patients undergoing CABG or other surgery where extracorporal circulation will be used.
You may not qualify if:
- raise in ischemic markers within 4 weeks
- ejection fraction \<30
- Atrial fibrilation
- Oral opioid treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2016
First Posted
December 15, 2016
Study Start
December 1, 2016
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
June 7, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share