NCT03367806

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,052

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

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

January 1, 1999

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

12.9 years

First QC Date

December 5, 2017

Last Update Submit

December 5, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cardiovascular mortality

    From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years

  • Cancer mortality

    From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 11, 2017

Study Start

January 1, 1999

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 11, 2017

Record last verified: 2017-12