Caffeine Consumption and Mortality in Diabetes | NCT03367806

Studies
Caffeine Consumption and Mortality in Diabetes

NCT03367806

Sponsor

João Sérgio Neves

Status

Completed

Last Update Posted

Dec 11, 2017Actual

Enrollment

3,052Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999Actual

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 5, 2017

First Submission Date that Met QC Criteria

Dec 5, 2017

First Posted Date

Dec 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2017

Last Update Posted Date

Dec 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,052Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Cancer mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided