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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: NaCl beverage; Dietary Supplement: Dietary nitrate beverage

• Registration Number: NCT01714674
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study Start: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01
• Primary Completion: 2013-03
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo beverage	NaCl beverage	the impact of placebo (no active substance) on exercise-induced cTnT release
Dietary nitrate beverage	Dietary nitrate beverage	The impact of dietary nitrate (active substance) on exercise-induced cTnT release

Primary Outcome Measures

Name	Time	Method
Cardiac troponin T	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

Name	Time	Method
Plasma nitrite	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.
Blood pressure	day	Blood pressure will be measured various time during the day.
Plasma nitrate	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.

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Netherlands