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

Early Phase 1CompletedNCT03011931

Entero Therapeutics40 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Celiac Disease

Interventions

SimvastatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Compare simvastatin metabolism with intestinal biopsies

Time frame: Within one month of visit

Secondary Outcomes

Villous height and crypt depth

As measured in intestinal biopsies

Time frame: Within 1 month of visit

Dietary interview

To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet

Time frame: At initial visit

Urinalysis

Looking for traces of gluten peptides

Time frame: Prior to administration of simvastatin and at the 3-hour mark

Serologic testing

tTG IgA titer level determination

Time frame: Prior to administration of simvastatin

DNA sampling

Genetic testing associated with celiac disease (DQ2 and DQ8)

Time frame: Prior to administration of simvastatin

Data from ClinicalTrials.gov

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