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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011931
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Immunogenics, LLC

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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Simvastatin Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Simvastatin Metabolism as a Test for Celiac Disease Activity
Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
Drug Information available for: Simvastatin

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 Name: Zocor




Primary Outcome Measures :
  1. Compare simvastatin metabolism with intestinal biopsies [ Time Frame: Within one month of visit ]

Secondary Outcome Measures :
  1. Villous height and crypt depth [ Time Frame: Within 1 month of visit ]
    As measured in intestinal biopsies

  2. 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

  3. Urinalysis [ Time Frame: Prior to administration of simvastatin and at the 3-hour mark ]
    Looking for traces of gluten peptides

  4. Serologic testing [ Time Frame: Prior to administration of simvastatin ]
    tTG IgA titer level determination

  5. DNA sampling [ Time Frame: Prior to administration of simvastatin ]
    Genetic testing associated with celiac disease (DQ2 and DQ8)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011931


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Immunogenics, LLC
Investigators
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Principal Investigator: Joseph A Murray, MD Mayo Clinic
Additional Information:
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Responsible Party: Immunogenics, LLC
ClinicalTrials.gov Identifier: NCT03011931    
Other Study ID Numbers: 15-007568
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors