Diabetes MellitusNCT00569959
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
A study testing fasting 12+ hours and Non-fasting in people with Diabetes Mellitus and Normal Glucose Metabolism, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia
- What is being tested?
- fasting 12+ hours and Non-fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Park Nicollet Health Services patients due for routine lipid measures
Who cannot join
- Unwilling or unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Internal and Family Medicine Clinics
Minneapolis, Minnesota, 55416
About this study
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.
- Conditions
- Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia
- Being tested
- fasting 12+ hours, Non-fasting
- Keywords
- fasting lipid measures, non-fasting lipid measures, clinical decision-making, LDL-Cholesterol
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasting 12+ hoursOther
fasting 12+ hours
Non-fastingOther
Non-fasting
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Other | Not described Receives: Other: fasting 12+ hours |
| Non-fasting | Other | Not described Receives: Other: Non-fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterol
Measured: Fasting 12+ hours vs. Non-fasting
Secondary outcomes (1)
Other lipid parameters
Measured: Fasting 12+ hours vs. non-fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startNov 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Investigators
- William Richards, MD, Principal investigator, Park Nicollet Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569959
- Sponsor's protocol ID
- 03363-05-A
- Status last verified
- Dec 2008
- First submitted
- 6 Dec 2007
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
- ClinicalTrials.gov ID
- NCT00569959
- Acronym / sponsor ID
- 03363-05-A
- Conditions
- Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia
- Keywords
- fasting lipid measures, non-fasting lipid measures, clinical decision-making, LDL-Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Other | Other: fasting 12+ hours |
| Non-fasting | Other | Other: Non-fasting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Park Nicollet Health Services patients due for routine lipid measures
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fasting 12+ hoursfasting 12+ hours | Other | Fasting |
| Non-fastingNon-fasting | Other | Non-fasting |
Primary outcome
LDL-Cholesterol
Time frame: Fasting 12+ hours vs. Non-fasting
1 secondary outcome
Other lipid parameters
Time frame: Fasting 12+ hours vs. non-fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Richards, MD principal investigator
Park Nicollet Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting 12+ hours and Non-fasting in people with Diabetes Mellitus and Normal Glucose Metabolism, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-Cholesterol (time frame: Fasting 12+ hours vs. Non-fasting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.