- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121755
CCK1R Function in Patient Leukocytes
Study Overview
Status
Conditions
Detailed Description
Subjects are volunteers who provide prospective informed consent to be entered into the Sangre Por Salud Biobank at Mountain Park Medical Center. These include men and women age 18-85 of Hispanic/Latino descent, who are not pregnant or have given birth in the previous 12 months, or who are nursing, and who have not been diagnosed with cancer in the previous three years. Two groups of patients are included, representing those who have not been diagnosed as having diabetes, and those with diabetes. Subjects undergo entry physical examination and standard metabolic phenotyping, with the non-diabetics also undergoing a 2-hour glucose tolerance test. Blood samples are also banked and available for other studies, such as the one now being described.
For the current study, 5 ml of blood will be coded and delivered in an anonymized form. Buffy coat cells will be isolated and infected ex vivo with a viral construct including the wild type CCK1R tagged with a fluorescent tag. Cells will be placed in culture overnight and harvested for quantitation of receptor expression and determination of CCK responsiveness and cholesterol content. These data will be correlated with selected relevant clinical, biochemical, and morphometric data.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- volunteers
Exclusion Criteria:
- Hispanic/Latino descent not pregnant, or given birth in the previous 12 months, or currently nursing not diagnosed with cancer in the past three years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Sangre Por Salud cohort members
Subjects entered in the Sangre Por Salud Biobank
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cellular cholesterol on leukocytes collected from the subjects
Time Frame: baseline
|
The cells will be lysed by sonication; neutral sterols will be extracted, and the cholesterol will be quantified using an assay.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurence J Miller, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-000131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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