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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
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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
Type 2 Diabetes Mellitus Dietary Supplement: Dietary nitrate beverage Dietary Supplement: NaCl beverage

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Blood pressure [ Time Frame: day ]
    Blood pressure will be measured various time during the day.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jan-Willem van Dijk, MSc +31(0)433881394 janwillem.vandijk@maastrichtuniversity.nl

Locations
Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands, 6214 AD
Sub-Investigator: Jan-Willem van Dijk, MSc         
Principal Investigator: Luc van Loon, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc van Loon, PhD Maastricht UMC

Additional Information:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01714674     History of Changes
Other Study ID Numbers: METC 12-3-033
NL41071.068.12 ( Other Identifier: ccmo )
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Maastricht University Medical Center:
cardiac troponin T
cTnT
exercise
dietary nitrate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases