Diurnal Triglyceridemia in Relation to Alcohol Intake | NCT01786421

Studies
Diurnal Triglyceridemia in Relation to Alcohol Intake

NCT01786421

Sponsor

Sint Franciscus Gasthuis

Status

Completed

Last Update Posted

Feb 8, 2013Estimated

Enrollment

273Actual

Phase

Not provided

Conditions

Healthy Subjects
Hyperlipidemias
Type 2 Diabetes Mellitus
Cardiovascular Diseases

Interventions

Not provided

Countries

Netherlands

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

Feb 2013

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

Not provided

Primary Completion Date

Dec 2005Actual

Completion Date

Not provided

First Submitted Date

Jan 29, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 8, 2013Estimated

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

Feb 5, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

273Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General population		Healthy volunteers,patients with hyperlipidemia,a known medical history of cardiovascular diseases or type 2 diabetes mellitus.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Gender differences in diurnal triglyceridemia by alcohol consumption		For 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Patients with:

Hyperlipidemia
Type 2 Diabetes Mellitus
Cardiovascular diseases

Exclusion Criteria:

Renal disease
Liver disease
Thyroid disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sint Franciscus Gasthuis		Rotterdam	Rotterdam	10900	Netherlands
Utrecht University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D003924	Diabetes Mellitus, Type 2
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided