Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes (NO troponin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01714674
First received: October 24, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Cardiac troponin T [ Time Frame: 9 hours, hourly time intervals ] [ Designated as safety issue: No ]
    Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.


Secondary Outcome Measures:
  • Plasma nitrate [ Time Frame: 9 hours, hourly time intervals ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood pressure will be measured various time during the day.


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01714674     History of Changes
Other Study ID Numbers: METC 12-3-033, NL41071.068.12
Study First Received: October 24, 2012
Last Updated: October 31, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on October 19, 2014