Back to resultsAssessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
Primary Purpose
Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fasting 12+ hours
Non-fasting
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring fasting lipid measures, non-fasting lipid measures, clinical decision-making, LDL-Cholesterol
Eligibility Criteria
Inclusion Criteria:
- Park Nicollet Health Services patients due for routine lipid measures
Exclusion Criteria:
- Unwilling or unable to provide consent
Sites / Locations
- Park Nicollet Internal and Family Medicine Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Fasting
Non-fasting
Arm Description
Outcomes
Primary Outcome Measures
LDL-Cholesterol
Secondary Outcome Measures
Other lipid parameters
Full Information
NCT ID
NCT00569959
First Posted
December 6, 2007
Last Updated
November 25, 2015
Sponsor
HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT00569959
Brief Title
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
Official Title
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HealthPartners Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia
Keywords
fasting lipid measures, non-fasting lipid measures, clinical decision-making, LDL-Cholesterol
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasting
Arm Type
Other
Arm Title
Non-fasting
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
fasting 12+ hours
Intervention Description
fasting 12+ hours
Intervention Type
Other
Intervention Name(s)
Non-fasting
Intervention Description
Non-fasting
Primary Outcome Measure Information:
Title
LDL-Cholesterol
Time Frame
Fasting 12+ hours vs. Non-fasting
Secondary Outcome Measure Information:
Title
Other lipid parameters
Time Frame
Fasting 12+ hours vs. non-fasting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Park Nicollet Health Services patients due for routine lipid measures
Exclusion Criteria:
Unwilling or unable to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Richards, MD
Organizational Affiliation
Park Nicollet Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park Nicollet Internal and Family Medicine Clinics
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
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