Type 2 Diabetes MellitusNO troponinNCT01714674
Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes
A study testing Dietary nitrate beverage and NaCl beverage in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dietary nitrate beverage and NaCl beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- exercise-induced cTnT release (>3ng/L)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht, 6214 AD
Jan-Willem van Dijk, MSc
Luc van Loon, PhD
About this study
Official title: The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dietary nitrate beverage, NaCl beverage
- Keywords
- cardiac troponin T, cTnT, exercise, dietary nitrate
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiomyopathy, Familial Restrictive, 3, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary nitrate beverageDietary supplement
ingestion of single dose NaNO3 beverage two hours prior to exercise bout
NaCl beverageDietary supplement
ingestion of single dose NaCl beverage two hours prior to exercise bout
| Study group | Role | What they receive |
|---|---|---|
| Placebo beverage | Placebo comparator | the impact of placebo (no active substance) on exercise-induced cTnT release Receives: Dietary Supplement: NaCl beverage |
| Dietary nitrate beverage | Active comparator | The impact of dietary nitrate (active substance) on exercise-induced cTnT release Receives: Dietary Supplement: Dietary nitrate beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac troponin T
Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Measured: 9 hours, hourly time intervals
Secondary outcomes (3)
Plasma nitrate
Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Measured: 9 hours, hourly time intervals
Plasma nitrite
Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
Measured: 9 hours, hourly time intervals
Blood pressure
Blood pressure will be measured various time during the day.
Measured: day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714674
- Sponsor's protocol ID
- METC 12-3-033
- Other IDs
- NL41071.068.12
- Acronym
- NO troponin
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01714674
- Acronym / sponsor ID
- NO troponin / METC 12-3-033
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- cardiac troponin T, cTnT, exercise, dietary nitrate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo beverage | Placebo comparator | Dietary Supplement: NaCl beveragethe impact of placebo (no active substance) on exercise-induced cTnT release |
| Dietary nitrate beverage | Active comparator | Dietary Supplement: Dietary nitrate beverageThe impact of dietary nitrate (active substance) on exercise-induced cTnT release |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- exercise-induced cTnT release (>3ng/L)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary nitrate beverageingestion of single dose NaNO3 beverage two hours prior to exercise bout | Dietary supplement | Dietary nitrate beverage |
| NaCl beverageingestion of single dose NaCl beverage two hours prior to exercise bout | Dietary supplement | Placebo beverage |
Primary outcome
Cardiac troponin T
Time frame: 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.
3 secondary outcomes
Plasma nitrate
Time frame: 9 hours, hourly time intervals
Plasma nitrite
Time frame: 9 hours, hourly time intervals
Blood pressure
Time frame: day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- research unitLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary nitrate beverage and NaCl beverage in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan-Willem van Dijk, MSc (+31(0)433881394, janwillem.vandijk@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac troponin T (time frame: 9 hours, hourly time intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.