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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dietary nitrate beverage
NaCl beverage
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring cardiac troponin T, cTnT, exercise, dietary nitrate

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht UMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo beverage

Dietary nitrate beverage

Arm Description

the impact of placebo (no active substance) on exercise-induced cTnT release

The impact of dietary nitrate (active substance) on exercise-induced cTnT release

Outcomes

Primary Outcome Measures

Cardiac troponin T
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
Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Plasma nitrite
Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Blood pressure
Blood pressure will be measured various time during the day.

Full Information

First Posted
October 24, 2012
Last Updated
October 31, 2012
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01714674
Brief Title
Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes
Acronym
NO troponin
Official Title
The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
cardiac troponin T, cTnT, exercise, dietary nitrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo beverage
Arm Type
Placebo Comparator
Arm Description
the impact of placebo (no active substance) on exercise-induced cTnT release
Arm Title
Dietary nitrate beverage
Arm Type
Active Comparator
Arm Description
The impact of dietary nitrate (active substance) on exercise-induced cTnT release
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary nitrate beverage
Intervention Description
ingestion of single dose NaNO3 beverage two hours prior to exercise bout
Intervention Type
Dietary Supplement
Intervention Name(s)
NaCl beverage
Intervention Description
ingestion of single dose NaCl beverage two hours prior to exercise bout
Primary Outcome Measure Information:
Title
Cardiac troponin T
Description
Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Time Frame
9 hours, hourly time intervals
Secondary Outcome Measure Information:
Title
Plasma nitrate
Description
Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Time Frame
9 hours, hourly time intervals
Title
Plasma nitrite
Description
Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Time Frame
9 hours, hourly time intervals
Title
Blood pressure
Description
Blood pressure will be measured various time during the day.
Time Frame
day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan-Willem van Dijk, MSc
Phone
+31(0)433881394
Email
janwillem.vandijk@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC
City
Maastricht
ZIP/Postal Code
6214 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Willem van Dijk, MSc
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD

12. IPD Sharing Statement

Links:
URL
http://www.m3-research.nl/
Description
research unit

Learn more about this trial

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

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