Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

January 13, 2020 updated by: Immunogenics, LLC

Simvastatin Metabolism as a Test for Celiac Disease Activity

To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gluten-free diet for at least 1 year
  2. Clinical endoscopy within the past month
  3. Biopsies must show no villous atrophy or villous blunting
  4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion Criteria:

  1. 1st degree relative with Celiac Disease
  2. Positive tTG IgA, already on simvastatin or statin agent
  3. Unable to stop non-steroidal or anti-inflammatory drugs
  4. Prior history of GI surgery other than appendectomy or cholecystectomy
  5. Taking drugs know to inhibit or activate CYP3A4
  6. Unable to avoid food known to inhibit CYP3A4
  7. History of a reaction to statin drugs in the past
  8. Pregnant or nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin
Simvastatin tablet, 20 mg, one time by mouth
Drug: Simvastatin
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
Other Names:
  • Zocor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare simvastatin metabolism with intestinal biopsies
Time Frame: Within one month of visit
Within one month of visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Villous height and crypt depth
Time Frame: Within 1 month of visit
As measured in intestinal biopsies
Within 1 month of visit
Dietary interview
Time Frame: At initial visit
To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
At initial visit
Urinalysis
Time Frame: Prior to administration of simvastatin and at the 3-hour mark
Looking for traces of gluten peptides
Prior to administration of simvastatin and at the 3-hour mark
Serologic testing
Time Frame: Prior to administration of simvastatin
tTG IgA titer level determination
Prior to administration of simvastatin
DNA sampling
Time Frame: Prior to administration of simvastatin
Genetic testing associated with celiac disease (DQ2 and DQ8)
Prior to administration of simvastatin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunogenics, LLC

Investigators

  • Principal Investigator: Joseph A Murray, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-007568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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