Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes (NO troponin)
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|ClinicalTrials.gov Identifier: NCT01714674|
Recruitment Status : Unknown
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : October 26, 2012
Last Update Posted : November 1, 2012
Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac injury. Previous research has shown that type 2 diabetic patients may experience large increments in cTnT levels over the subsequent hours following a single bout of moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent evidence indicates that ingestion of dietary nitrates dramatically increases the bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion injury.
The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT levels following exercise in type 2 diabetic patients.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Dietary nitrate beverage Dietary Supplement: NaCl beverage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||May 2013|
Placebo Comparator: Placebo beverage
the impact of placebo (no active substance) on exercise-induced cTnT release
Dietary Supplement: NaCl beverage
ingestion of single dose NaCl beverage two hours prior to exercise bout
Active Comparator: Dietary nitrate beverage
The impact of dietary nitrate (active substance) on exercise-induced cTnT release
Dietary Supplement: Dietary nitrate beverage
ingestion of single dose NaNO3 beverage two hours prior to exercise bout
- Cardiac troponin T [ Time Frame: 9 hours, hourly time intervals ]Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
- Plasma nitrate [ Time Frame: 9 hours, hourly time intervals ]Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
- Plasma nitrite [ Time Frame: 9 hours, hourly time intervals ]Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
- Blood pressure [ Time Frame: day ]Blood pressure will be measured various time during the day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714674
|Contact: Jan-Willem van Dijk, MSc||+31(0)firstname.lastname@example.org|
|Maastricht, Netherlands, 6214 AD|
|Sub-Investigator: Jan-Willem van Dijk, MSc|
|Principal Investigator: Luc van Loon, PhD|
|Principal Investigator:||Luc van Loon, PhD||Maastricht UMC|