Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

NCT ID: NCT01854242

Last Updated: 2020-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.

Detailed Description

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The purpose of this research study is to understand the relationship between IBD and GSD type Ia. The Investigators will be attempting to develop a blood test which will be aimed at the participants diagnosis of IBD.

As a participant in this research study, a blood sample will be collected during your admission to the University of Florida. This will not affect the length of stay of your scheduled visit. There will be no scheduled clinic follow-up.

Conditions

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Inflammatory Bowel Disease Glycogen Storage Disease Type Ia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glycogen Storage Disease type Ia patients

The participants will have one blood draw for this study. The test will be performed on the blood.

Glycogen Storage Disease type Ia patients

Intervention Type OTHER

The participants will have one blood draw for this study. The test will be performed on the blood.

Interventions

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Glycogen Storage Disease type Ia patients

The participants will have one blood draw for this study. The test will be performed on the blood.

Intervention Type OTHER

Other Intervention Names

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GSD Type Ia

Eligibility Criteria

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Inclusion Criteria

* Anyone with Glycogen Storage Disease type Ia

Exclusion Criteria

* Anyone where the amount of blood needed to complete the Prometheus test exceeds 3ml/kg.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prometheus Laboratories

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole T Lawrence, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

David A Weinstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida and Shands

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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COL13IBD01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201300312

Identifier Type: -

Identifier Source: org_study_id

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