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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Celiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Simvastatin

Simvastatin tablet, 20 mg, one time by mouth

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

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

Interventions

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Simvastatin

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

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes