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



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:March 2016
End Date:March 2019
Contact:Chad Hinson
Email:hinson.chadrick@mayo.edu
Phone:507-266-0237

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Simvastatin Metabolism as a Test for Celiac Disease Activity

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.

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
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-266-7842
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