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

Type 2 Diabetes Mellitus Clinical Trial

— NO troponin  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01714674
• Other study ID #: METC 12-3-033
• Secondary ID: NL41071.068.12
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2012
• Last updated: October 31, 2012
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: Jan-Willem van Dijk, MSc
• Phone: +31(0)433881394
• Email: janwillem.vandijk[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Dietary nitrate beverage
ingestion of single dose NaNO3 beverage two hours prior to exercise bout
• NaCl beverage
ingestion of single dose NaCl beverage two hours prior to exercise bout

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Blood pressure	Blood pressure will be measured various time during the day.	day	No

External Links

•   research unit