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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Dietary nitrate beverage; Dietary Supplement: NaCl beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT01714674

NL41071.068.12 (Other Identifier)

METC 12-3-033

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Placebo beverage

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: NaCl beverage

Dietary nitrate beverage

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary nitrate beverage