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

October 31, 2012 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6214 AD
        • Recruiting
        • Maastricht UMC
        • Sub-Investigator:
          • Jan-Willem van Dijk, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 hours, hourly time intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 hours, hourly time intervals
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.
9 hours, hourly time intervals
Blood pressure
Time Frame: day
Blood pressure will be measured various time during the day.
day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Luc van Loon, PhD, Maastricht UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 12-3-033
  • NL41071.068.12 (Other Identifier: ccmo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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