NCT01714674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 24, 2012

Last Update Submit

October 31, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

cardiac troponin TcTnTexercisedietary nitrate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Plasma nitrate

    9 hours, hourly time intervals

  • Plasma nitrite

    9 hours, hourly time intervals

  • Blood pressure

    day

Study Arms (2)

Placebo beverage

PLACEBO COMPARATOR

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

Dietary Supplement: NaCl beverage

Dietary nitrate beverage

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary nitrate beverage

Interventions

Dietary nitrate beverageDIETARY_SUPPLEMENT

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

Dietary nitrate beverage
NaCl beverageDIETARY_SUPPLEMENT

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

Placebo beverage

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • exercise-induced cTnT release (\>3ng/L)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, 6214 AD, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiomyopathy, Familial Restrictive, 3Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Luc van Loon, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan-Willem van Dijk, MSc

CONTACT

+31(0)433881394janwillem.vandijk@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 26, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

NL(1)