CCK1R Function in Patient Leukocytes

Obesity Clinical Trial

Official title:

CCK1R Function in Patient Leukocytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121755
• Other study ID #: 15-000131
• Status: Completed
• Phase: N/A
• First received: April 17, 2017
• Last updated: April 19, 2017
• Start date: January 21, 2015
• Est. completion date: April 14, 2017

Study information

• Verified date: April 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The type 1 cholecystokinin receptor (CCK1R) is a potential target for the treatment of obesity, due to the ability of this GI hormone to elicit satiety. However, this receptor has been shown to be sensitive to the cholesterol content of the membrane in which it is expressed. Because some patients who might be candidates for the use of CCK agonists to treat their obesity and co-morbidities, the goal of this study is to determine how metabolic abnormalities might affect the responsiveness of this receptor to CCK. Because the normal site mediating CCK-stimulated satiety is on vagal afferent neurons that cannot easily be studied, we will collect buffy coat cells from a peripheral blood sample from patients involved in the Sangre Por Salud Biobank at Mountain Park Medical Center. Ex vivo, the CCK1R will be expressed on these cells and will be functionally characterized, and the cholesterol content of the cells will be assayed. These data will be correlated with the clinical, biochemical, and metabolic phenotypic data collected as part of the parent study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 14, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cellular cholesterol on leukocytes collected from the subjects	The cells will be lysed by sonication; neutral sterols will be extracted, and the cholesterol will be quantified using an assay.	baseline