A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

NCT03805633 | Withdrawn

• 1 other identifier: IRB-300000289
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoidosis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in glucose during oral glucose tolerance test (oGTT)

  Baseline

Secondary Outcomes (3)

• Change in C peptide over oGTT

  Baseline

• Change in insulin response oGTT

  Baseline

• Hemoglobin A1c (HbA1c)

  Baseline

Study Arms (3)

Sarcoidosis Patients

Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.

Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas

Diabetes Patients

Patients followed by UAB Endocrinology with diabetes mellitus.

Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas

Sarcoidosis and Diabetes patients

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

Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas

Interventions

Venous blood sample DIAGNOSTIC_TEST

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

Diabetes Patients; Sarcoidosis Patients; Sarcoidosis and Diabetes patients

Ultrasound of pancreas DIAGNOSTIC_TEST

Ultrasound of pancreas will be obtained on all study participants.

Diabetes Patients; Sarcoidosis Patients; Sarcoidosis and Diabetes patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One group will consist of patients referred to or followed at UAB pulmonary clinic with an established diagnosis of sarcoidosis without diabetes mellitus. A second group will consist of patients referred to or followed at UAB pulmonary and/or endocrinology clinic with diagnoses of both sarcoidosis and diabetes mellitus. A third group will consist of patients referred to or followed at UAB endocrinology clinic with a diagnosis of diabetes mellitus without sarcoidosis.

You may qualify if:

• 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).

You may not qualify if:

• Type 1 diabetes and/or chronic use of corticosteroids.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 16, 2019
• Study Start: February 2, 2018
• Primary Completion: July 31, 2019
• Study Completion: January 31, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 1 month after publication
• Access Criteria: IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).

Locations

US (1)