Diabetes MellitusNCT03367806
Caffeine Consumption and Mortality in Diabetes
An observational study of Diabetes Mellitus, run by João Sérgio Neves.
Trial summary
Previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. Furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 3,052 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Dec 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Who may be able to join
- NHANES participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes
Who cannot join
- Implausible alimentary reports (defined as consumption of less than 500 kcal/day or more than 3500 kcal/day)
- Missing information on caffeine consumption
- Missing information on mortality
About this study
Official title: Caffeine Consumption and Mortality in Diabetes: an Analysis of National Health and Nutrition Examination Survey (NHANES) 1999-2010
Previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. Furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. Prospective studies showed that coffee consumption might be associated with reduction in the incidence of type 2 diabetes. Although caffeine consumption appears to be associated with a decreased risk of developing type 2 diabetes, the relationship between caffeine consumption and mortality in patients with diabetes remains uncertain. The current analysis aimed to assess the effects of caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality among patients with diabetes.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality as assessed by NHANES linked National Death Index public-access
Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Secondary outcomes (2)
Cardiovascular mortality
Cardiovascular mortality as assessed by NHANES linked National Death Index public-access
Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Cancer mortality
Cancer mortality as assessed by NHANES linked National Death Index public-access
Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startJan 1999
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- João Sérgio Neves
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, João Sérgio Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367806
- Sponsor's protocol ID
- Caffeine-DM
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine Consumption and Mortality in Diabetes: an Analysis of National Health and Nutrition Examination Survey (NHANES) 1999-2010
- ClinicalTrials.gov ID
- NCT03367806
- Acronym / sponsor ID
- Caffeine-DM
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,052 participants (actual)
- Lead sponsor
- João Sérgio NevesUniversity, hospital or other
- Study start
- Jan 1999 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Dec 2017 (actual)
- 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.
Previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. Furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. Prospective studies showed that coffee consumption might be associated with reduction in the incidence of type 2 diabetes. Although caffeine consumption appears to be associated with a decreased risk of developing type 2 diabetes, the relationship between caffeine consumption and mortality in patients with diabetes remains uncertain. The current analysis aimed to assess the effects of caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality among patients with diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Key inclusion criteria (1 listed)
- NHANES participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes
Key exclusion criteria (3 listed)
- Implausible alimentary reports (defined as consumption of less than 500 kcal/day or more than 3500 kcal/day)
- Missing information on caffeine consumption
- Missing information on mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
All-cause mortality as assessed by NHANES linked National Death Index public-access
2 secondary outcomes
Cardiovascular mortality
Time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Cancer mortality
Time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by João Sérgio Neves.
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 3 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: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years). 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 11 Dec 2017.