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

Simvastatin Metabolism as a Test for Celiac Disease Activity

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03011931

Enrollment

Registered

2017-01-06

Start date

2016-03-31

Completion date

2019-02-28

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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.

Interventions

DRUGSimvastatin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Compare simvastatin metabolism with intestinal biopsies	Within one month of visit

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026