Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Dietary nitrate beverage
* Dietary Supplement: NaCl beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: exercise-induced cTnT release (>3ng/L) Exclusion Criteria: HbA1c <6.0% or >10.0% morbid obesity (BMI>35 kg/m2) incident cardiovascular events in the last year (heart attack, stroke use medication which contain nitrates and/or having vasodilatory effects

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo beverage<br>the impact of placebo (no active substance) on exercise-induced cTnT release | Dietary Supplement: NaCl beverage<br>* ingestion of single dose NaCl beverage two hours prior to exercise bout<br>|
| Active Comparator: Dietary nitrate beverage<br>The impact of dietary nitrate (active substance) on exercise-induced cTnT release | Dietary Supplement: Dietary nitrate beverage<br>* ingestion of single dose NaNO3 beverage two hours prior to exercise bout<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac troponin T | Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise. | 9 hours, hourly time intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma nitrate | Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise. | 9 hours, hourly time intervals | 
| Plasma nitrite | Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise. | 9 hours, hourly time intervals | 
| Blood pressure | Blood pressure will be measured various time during the day. | day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac troponin T, cTnT, exercise, dietary nitrate