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NCT03011931 Clinical Trial

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

Celiac Disease Clinical Trial

Official title:
Simvastatin Metabolism as a Test for Celiac Disease Activity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03011931
Other study ID # 15-007568
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date March 2016
Est. completion date February 2019

Study information
Verified date January 2020
Source Immunogenics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Simvastatin
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Immunogenics, LLC

Country where clinical trial is conducted

United States, 

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