A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus; Sarcoidosis
• Intervention / Treatment: Diagnostic test: Venous blood sample; Diagnostic test: Ultrasound of pancreas

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sarcoidosis Patients; Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.	Diagnostic test: Venous blood sample; Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.; Diagnostic test: Ultrasound of pancreas; Ultrasound of pancreas will be obtained on all study participants.
Diabetes Patients; Patients followed by UAB Endocrinology with diabetes mellitus.	Diagnostic test: Venous blood sample; Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.; Diagnostic test: Ultrasound of pancreas; 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.	Diagnostic test: Venous blood sample; Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.; Diagnostic test: Ultrasound of pancreas; Ultrasound of pancreas will be obtained on all study participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in glucose during oral glucose tolerance test (oGTT)	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in C peptide over oGTT	Baseline
Change in insulin response oGTT	Baseline
Hemoglobin A1c (HbA1c)	Baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Endocrine System Diseases; Diabetes Mellitus; Sarcoidosis; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: IRB-300000289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected individual participant data (IPD)
• IPD Sharing Time Frame: starting 1 month after publication
• IPD Sharing Access Criteria: IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No