To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects

NCT01420328 | Completed Results

• 1 other identifier: MED7120311A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on the use of Vytorin to study inflammatory markers in subjects with normal cholesterol.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in CD68 mRNA Expression in MNC

  Percent change from baseline (0 week) in cream challenge induced change in CD68 mRNA expression in MNC after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)/ change at 0 week\*100

  0 weeks and 6 weeks

Secondary Outcomes (3)

• Change in Cream-induced Expression of CD16

  6 weeks

• Change IL-1b mRNA Expression

  6 weeks

• Change in Plasma Endotoxin (LPS) Concentrations

  6 weeks

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Obese subjects treated with placebo for 6 weeks

Drug: Placebo

Vytorin Arm

ACTIVE COMPARATOR

Obese subjects treated with Vytorin for 6 weeks

Drug: Vytorin

Interventions

Vytorin DRUG

Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) for 6 weeks

Also known as: Ezetimibi/Simvastatin 10/40

Vytorin Arm

Placebo DRUG

Placebo treatment for 6 weeks

Also known as: Placebo for Vytorin

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65years.
• Obese BMI \>30kg/m2
• LDL cholesterol \>100 mg/dl
• Written and informed consent signed and dated 5. Not on any vitamin/antioxidants

You may not qualify if:

• On any antilipid agents.
• Triglyceride \>500mg/dl
• Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months
• Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids
• Hepatic disease
• Renal impairment
• History of drug or alcohol abuse
• Participation in any other concurrent clinical trial
• Use of an investigational agent or therapeutic regimen within 30 days of study.
• Smoker
• Pregnancy
• Premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation 13. Anemia with hemoglobin \<12 g/dl

Sponsors & Collaborators

• University at Buffalo: lead
• Kaleida Health: collaborator

Study Sites (1)

Diabetes Endocrinology Center of WNY

Buffalo, New York, 14209, United States

Location

Related Publications (1)

• Ghanim H, Green K, Abuaysheh S, Patel R, Batra M, Chaudhuri A, Makdissi A, Kuhadiya ND, Dandona P. Ezetimibe and simvastatin combination inhibits and reverses the pro-inflammatory and pro-atherogenic effects of cream in obese patients. Atherosclerosis. 2017 Aug;263:278-286. doi: 10.1016/j.atherosclerosis.2017.06.010. Epub 2017 Jun 7.

  PMID: 28711708 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Simvastatin; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

no limitations

Results Point of Contact

• Title: Dr. Husam Ghanim
• Organization: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA

ghanim@buffalo.edu

7169574325

Study Officials

• Paresh Dandona, MD

  University at Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: August 19, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-03

Locations

US (1)