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Trial record 8 of 34 for:    Open Studies | "Malabsorption Syndromes" | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Joseph A. Murray, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03011931
First received: October 3, 2016
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

Condition Intervention
Celiac Disease
Drug: Simvastatin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Simvastatin Metabolism as a Test for Celiac Disease Activity

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Compare simvastatin metabolism with intestinal biopsies [ Time Frame: Within one month of visit ]

Secondary Outcome Measures:
  • Villous height and crypt depth [ Time Frame: Within 1 month of visit ]
    As measured in intestinal biopsies

  • 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

  • Urinalysis [ Time Frame: Prior to administration of simvastatin and at the 3-hour mark ]
    Looking for traces of gluten peptides

  • Serologic testing [ Time Frame: Prior to administration of simvastatin ]
    tTG IgA titer level determination

  • DNA sampling [ Time Frame: Prior to administration of simvastatin ]
    Genetic testing associated with celiac disease (DQ2 and DQ8)


Estimated Enrollment: 50
Study Start Date: March 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin
Simvastatin tablet, 20 mg, one time by mouth
Drug: Simvastatin
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
Other Name: Zocor

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03011931

Contacts
Contact: Chad Hinson 507-266-0237 hinson.chadrick@mayo.edu
Contact: Carol Van Dyke 207-266-7842 vandyke.carol@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carol Van Dyke    507-266-7842    vandyke.carol@mayo.edu   
Contact: Chad Hinson    507-266-0237    hinson.chadrick@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph A Murray, MD Mayo Clinic
  More Information

Responsible Party: Joseph A. Murray, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03011931     History of Changes
Other Study ID Numbers: 15-007568
Study First Received: October 3, 2016
Last Updated: January 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Malabsorption Syndromes
Celiac Disease
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2017