NCT03121755

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

April 17, 2017

Last Update Submit

April 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sangre Por Salud cohort members

Subjects entered in the Sangre Por Salud Biobank

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects in Sangre Por Salud Biobank

You may qualify if:

  • volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Desai AJ, Dong M, Langlais BT, Dueck AC, Miller LJ. Cholecystokinin responsiveness varies across the population dependent on metabolic phenotype. Am J Clin Nutr. 2017 Aug;106(2):447-456. doi: 10.3945/ajcn.117.156943. Epub 2017 Jun 7.

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Laurence J Miller, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biochemistry and Molecular Biology and Medicine and Pharmacology

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 20, 2017

Study Start

January 21, 2015

Primary Completion

March 1, 2017

Study Completion

April 14, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04