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

NCT ID: NCT01714674

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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cardiac troponin T cTnT exercise dietary nitrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo beverage

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

Group Type PLACEBO_COMPARATOR

NaCl beverage

Intervention Type DIETARY_SUPPLEMENT

ingestion of single dose NaCl beverage two hours prior to exercise bout

Dietary nitrate beverage

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

Group Type ACTIVE_COMPARATOR

Dietary nitrate beverage

Intervention Type DIETARY_SUPPLEMENT

ingestion of single dose NaNO3 beverage two hours prior to exercise bout

Interventions

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Dietary nitrate beverage

ingestion of single dose NaNO3 beverage two hours prior to exercise bout

Intervention Type DIETARY_SUPPLEMENT

NaCl beverage

ingestion of single dose NaCl beverage two hours prior to exercise bout

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc van Loon, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

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Maastricht UMC

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Jan-Willem van Dijk, MSc

Role: CONTACT

Phone: +31(0)433881394

Email: [email protected]

Related Links

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Other Identifiers

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METC 12-3-033

Identifier Type: -

Identifier Source: org_study_id

NL41071.068.12

Identifier Type: OTHER

Identifier Source: secondary_id