Assessment of Non-Fasting vs. Fasting Lipid Measures in D... | NCT00569959

Studies
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients

NCT00569959

Sponsor

HealthPartners Institute

Status

Completed

Last Update Posted

Nov 26, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus
Normal Glucose Metabolism
Hyperlipidemia

Interventions

fasting 12+ hours
Non-fasting

Countries

United States

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 2008

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

Nov 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Dec 6, 2007

First Submission Date that Met QC Criteria

Dec 7, 2007

First Posted Date

Dec 10, 2007Estimated

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

Nov 25, 2015

Last Update Posted Date

Nov 26, 2015Estimated

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

Description Module

Brief Summary

This study will examine whether fasting and non-fasting lipid measures can provide similar clinical information in order to guide lipid management by primary physicians. It will compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fasting	Other		Other: fasting 12+ hours
Non-fasting	Other		Other: Non-fasting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fasting 12+ hours	Other	fasting 12+ hours	Fasting
Non-fasting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL-Cholesterol		Fasting 12+ hours vs. Non-fasting

Secondary Outcomes

Measure	Description	Time Frame
Other lipid parameters		Fasting 12+ hours vs. non-fasting

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Park Nicollet Health Services patients due for routine lipid measures

Exclusion Criteria:

Unwilling or unable to provide consent

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Richards, MD	Park Nicollet Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Park Nicollet Internal and Family Medicine Clinics		Minneapolis	Minnesota	55416	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D006949	Hyperlipidemias

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