Cholesterol Clinical Trial
Official title:
Cholesterol Mobilization and Adipocyte Function in Humans
NCT number | NCT03729141 |
Other study ID # | IRB00023743 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | December 2019 |
Verified date | July 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypothesis: increasing dietary cholesterol in humans will increase visceral, but not
subcutaneous adipocyte size, free cholesterol content, and inflammatory gene expression.
Visceral and abdominal subcutaneous adipose tissue biopsies will be obtained from non-obese
subjects undergoing elective abdominal surgery at Wake Forest Baptist Medical Center after 3
weeks of zero (control) or 1g dietary cholesterol supplementation. Blood samples will also be
taken before and after 3 weeks of dietary supplementation (0 vs. 1g dietary cholesterol) to
measure plasma lipids levels, and ex vivo monocyte chemotaxis. Blood will also be used to
isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies.
Measurements of adipocyte size, free cholesterol content, and inflammatory gene and protein
expression in the adipose tissue biopsies to test the hypothesis. Adipocytes and the stromal
vascular fraction will be isolated and evaluated for CD14+ macrophages for RNA extraction and
storage for future transcriptome analysis.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age:18 to 70 years old - Operated on by one of the study team surgeons at Wake Forest Baptist Medical Center. Exclusion Criteria: - History of liver disease (e.g., autoimmune hepatitis, Wilson's disease, hemochromatosis, 1 anti-trypsin deficiency), as determined by chart review - Childs A, B, or C cirrhosis, as determined by chart review - Present diagnosis/treatment of malignancy other than non-melanoma skin cancer - Baseline INR > 1.8, as determined by chart review or need for continuous anticoagulation with warfarin or heparin - Platelets <50,000 as determined by chart review - Active immunomodulation therapy for chronic inflammatory diseases, including but not limited to rheumatoid arthritis, psoriasis, SLE, sarcoidosis, or inflammatory bowel disease - Diabetes mellitus requiring treatment with oral agents or insulin - Taking Questran, Colestid, or Zetia - BMI over 30 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma lipid levels | Blood samples will be collected from subjects at baseline and at the time of surgery in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery. Plasma lipid levels will be measured. In addition blood will be used to isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies. | up to 12 weeks | |
Other | Ex vivo monocyte chemotaxis | Blood samples will be collected from subjects at baseline and at the time of surgery in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery. Ex vivo monocyte chemotaxis will be measured. In addition blood will be used to isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies. | up to 12 weeks | |
Other | Gene expression | Visceral and subcutaneous adipose tissue will be collected from subjects in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery. Tissue samples will be taken from non-obese participants undergoing elective abdominal surgery to be used to measure inflammatory gene expression. | within 20 weeks of surgery. | |
Primary | Plasma total | Plasma will be used to measure plasma total | up to 6 weeks after surgery | |
Primary | Adipocyte size | Adipocyte size will be evaluated by histology by microscopic examination and morphometry. | within 6 weeks after surgery | |
Primary | Lipoprotein cholesterol levels | Plasma will be used to measure lipoprotein cholesterol levels. | up to 6 weeks after surgery |
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