NCT00566267

Brief Summary

People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
Last Updated

December 3, 2007

Status Verified

November 1, 2007

First QC Date

November 29, 2007

Last Update Submit

November 30, 2007

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol

    8 weeks of treatment

Secondary Outcomes (2)

  • Other lipid measures

    8 weeks of treatment

  • Safety and tolerability

    8 weeks treatment

Study Arms (1)

2

EXPERIMENTAL

Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg

Drug: simvastatin 20 mg/ezetimibe

Interventions

simvastatin 20 mg/ezetimibeDRUG

see protocol

Also known as: Low carb diet plus simvastatin 20 mg
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderately obese with hyperlipidemia

You may not qualify if:

  • Recent unstable heart or lung condition
  • Current use of other lipid modifying drugs
  • Hepatic disease
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.

    PMID: 20435205DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

SimvastatinEzetimibe

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Frederick F Samaha, M.D.

    Philadelphia VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

April 1, 2006

Study Completion

November 1, 2007

Last Updated

December 3, 2007

Record last verified: 2007-11