Back to resultsSimvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
Primary Purpose
Celiac Disease
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional diagnostic trial for Celiac Disease
Eligibility Criteria
Inclusion Criteria:
- Gluten-free diet for at least 1 year
- Clinical endoscopy within the past month
- Biopsies must show no villous atrophy or villous blunting
- Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
Exclusion Criteria:
- 1st degree relative with Celiac Disease
- Positive tTG IgA, already on simvastatin or statin agent
- Unable to stop non-steroidal or anti-inflammatory drugs
- Prior history of GI surgery other than appendectomy or cholecystectomy
- Taking drugs know to inhibit or activate CYP3A4
- Unable to avoid food known to inhibit CYP3A4
- History of a reaction to statin drugs in the past
- Pregnant or nursing women
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Simvastatin
Arm Description
Simvastatin tablet, 20 mg, one time by mouth
Outcomes
Primary Outcome Measures
Compare simvastatin metabolism with intestinal biopsies
Secondary Outcome Measures
Villous height and crypt depth
As measured in intestinal biopsies
Dietary interview
To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
Urinalysis
Looking for traces of gluten peptides
Serologic testing
tTG IgA titer level determination
DNA sampling
Genetic testing associated with celiac disease (DQ2 and DQ8)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011931
Brief Title
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
Official Title
Simvastatin Metabolism as a Test for Celiac Disease Activity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunogenics, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.
Detailed Description
A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Simvastatin tablet, 20 mg, one time by mouth
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
Primary Outcome Measure Information:
Title
Compare simvastatin metabolism with intestinal biopsies
Time Frame
Within one month of visit
Secondary Outcome Measure Information:
Title
Villous height and crypt depth
Description
As measured in intestinal biopsies
Time Frame
Within 1 month of visit
Title
Dietary interview
Description
To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
Time Frame
At initial visit
Title
Urinalysis
Description
Looking for traces of gluten peptides
Time Frame
Prior to administration of simvastatin and at the 3-hour mark
Title
Serologic testing
Description
tTG IgA titer level determination
Time Frame
Prior to administration of simvastatin
Title
DNA sampling
Description
Genetic testing associated with celiac disease (DQ2 and DQ8)
Time Frame
Prior to administration of simvastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gluten-free diet for at least 1 year
Clinical endoscopy within the past month
Biopsies must show no villous atrophy or villous blunting
Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
Exclusion Criteria:
1st degree relative with Celiac Disease
Positive tTG IgA, already on simvastatin or statin agent
Unable to stop non-steroidal or anti-inflammatory drugs
Prior history of GI surgery other than appendectomy or cholecystectomy
Taking drugs know to inhibit or activate CYP3A4
Unable to avoid food known to inhibit CYP3A4
History of a reaction to statin drugs in the past
Pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Murray, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
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