A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

NCT ID: NCT03805633

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2020-01-31

Brief Summary

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The purpose of the study is to determine the characteristics of patients with diabetes and sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin levels, and 2-hour glucose tolerance test results on the study population as well as collecting clinical data from records. Three groups of patients will be identified from pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first group will have a diagnosis of sarcoidosis without diabetes, the second group will have a diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate this number to be less than 100. These patients will be asked in person during an office visit to join the study. For each patient who agrees to join, at a clinic visit, investigators will review and sign consent. Following the visit or at a time convenient for each patient, study subjects will undergo a fasting plasma venous sample collection for a hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test. The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared between the groups and to historical published control data via T test comparisons. At a later separate visit, patients recruited will undergo ultrasound of the pancreas to assess pancreatic size and morphology.

Detailed Description

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Conditions

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Sarcoidosis Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sarcoidosis Patients

Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.

Venous blood sample

Intervention Type DIAGNOSTIC_TEST

Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.

Ultrasound of pancreas

Intervention Type DIAGNOSTIC_TEST

Ultrasound of pancreas will be obtained on all study participants.

Diabetes Patients

Patients followed by UAB Endocrinology with diabetes mellitus.

Venous blood sample

Intervention Type DIAGNOSTIC_TEST

Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.

Ultrasound of pancreas

Intervention Type DIAGNOSTIC_TEST

Ultrasound of pancreas will be obtained on all study participants.

Sarcoidosis and Diabetes patients

Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.

Venous blood sample

Intervention Type DIAGNOSTIC_TEST

Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.

Ultrasound of pancreas

Intervention Type DIAGNOSTIC_TEST

Ultrasound of pancreas will be obtained on all study participants.

Interventions

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Venous blood sample

Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.

Intervention Type DIAGNOSTIC_TEST

Ultrasound of pancreas

Ultrasound of pancreas will be obtained on all study participants.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Any adult patient referred to or followed in UAB pulmonary clinic with an established diagnosis of sarcoidosis. Any adult patient followed in UAB endocrinology clinic with a diagnosis of diabetes mellitus (excluding type 1 diabetes).

Exclusion Criteria

* Type 1 diabetes and/or chronic use of corticosteroids.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Fernando Ovalle

Medical Doctor, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300000289

Identifier Type: -

Identifier Source: org_study_id