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NCT03367806 Clinical Trial

Caffeine Consumption and Mortality in Diabetes

Diabetes Mellitus Clinical Trial

Official title:
Caffeine Consumption and Mortality in Diabetes: an Analysis of National Health and Nutrition Examination Survey (NHANES) 1999-2010

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03367806
Other study ID # Caffeine-DM
Secondary ID
Status Completed
Phase N/A
First received December 5, 2017
Last updated December 5, 2017
Start date January 1999
Est. completion date December 2011

Study information
Verified date December 2017
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 3052
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- NHANES participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
João Sérgio Neves

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality All-cause mortality as assessed by NHANES linked National Death Index public-access From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Secondary Cardiovascular mortality Cardiovascular mortality as assessed by NHANES linked National Death Index public-access From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
Secondary Cancer mortality Cancer mortality as assessed by NHANES linked National Death Index public-access From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years
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