NCT01786421

Brief Summary

The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

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

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

First QC Date

January 29, 2013

Last Update Submit

February 5, 2013

Conditions

Healthy SubjectsHyperlipidemiasType 2 Diabetes MellitusCardiovascular Diseases

Keywords

EthanolLipemiaPostprandialTriglyceride

Outcome Measures

Primary Outcomes (1)

  • Determination of diurnal triglyceridemia depend on alcohol intake

    Capillary triglyceridemia was measured by a triglyceride testing device on six fixed time-points.

    For 3 days.

Secondary Outcomes (1)

  • Gender differences in diurnal triglyceridemia by alcohol consumption

    For 3 days

Study Arms (1)

General population

Healthy volunteers,patients with hyperlipidemia,a known medical history of cardiovascular diseases or type 2 diabetes mellitus.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects were healthy volunteers or patients with hyperlipidemia or a known medical history of cardiovascular diseases, type 2 diabetes mellitus participating in several clinical studies with the same protocol, aimed to investigate factors influencing postprandial lipemia

You may qualify if:

  • Healthy volunteers
  • Patients with:
  • Hyperlipidemia
  • Type 2 Diabetes Mellitus
  • Cardiovascular diseases

You may not qualify if:

  • Renal disease
  • Liver disease
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sint Franciscus Gasthuis

Rotterdam, Rotterdam, 10900, Netherlands

Location

Utrecht University Medical Center

Utrecht, Utrecht, Netherlands

Location

MeSH Terms

Conditions

HyperlipidemiasDiabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 8, 2013

Primary Completion

December 1, 2005

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

NL(2)