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Completed

NCT Number: NCT03011931

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

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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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gluten-free diet for at least 1 year
  • Clinical endoscopy within the past month
  • Biopsies must show no villous atrophy or villous blunting
  • Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion criteria

  • 1st degree relative with Celiac Disease
  • Positive tTG IgA, already on simvastatin or statin agent
  • Unable to stop non-steroidal or anti-inflammatory drugs
  • Prior history of GI surgery other than appendectomy or cholecystectomy
  • Taking drugs know to inhibit or activate CYP3A4
  • Unable to avoid food known to inhibit CYP3A4
  • History of a reaction to statin drugs in the past
  • Pregnant or nursing women

Treatment and study plan

simvastatin

Drug

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

Other names: Zocor

Primary outcomes

  1. Compare simvastatin metabolism with intestinal biopsies

    Time frame: Within one month of visit

Secondary outcomes

  1. Villous height and crypt depth

    Time frame: Within 1 month of visit

    As measured in intestinal biopsies

  2. Dietary interview

    Time frame: At initial visit

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

  3. Urinalysis

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

    Looking for traces of gluten peptides

  4. Serologic testing

    Time frame: Prior to administration of simvastatin

    tTG IgA titer level determination

  5. DNA sampling

    Time frame: Prior to administration of simvastatin

    Genetic testing associated with celiac disease (DQ2 and DQ8)

Sponsors and collaborators

Lead sponsor

Entero Therapeutics

Industry

Collaborators

  • Immunogenics, LLC

Registry information

Official study title

Simvastatin Metabolism as a Test for Celiac Disease Activity

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2017
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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