A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

Withdrawn

• Conditions: Diabetes Mellitus; Sarcoidosis
• Interventions: Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas

• Registration Number: NCT03805633
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study Start: 2018-02-02
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-16
• Primary Completion: 2019-07-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes Patients	Venous blood sample	Patients followed by UAB Endocrinology with diabetes mellitus.
Sarcoidosis Patients	Venous blood sample	Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.
Sarcoidosis Patients	Ultrasound of pancreas	Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.
Sarcoidosis and Diabetes patients	Venous blood sample	Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.
Diabetes Patients	Ultrasound of pancreas	Patients followed by UAB Endocrinology with diabetes mellitus.
Sarcoidosis and Diabetes patients	Ultrasound of pancreas	Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.

Primary Outcome Measures

Name	Time	Method
Change in glucose during oral glucose tolerance test (oGTT)	Baseline

Secondary Outcome Measures

Name	Time	Method
Change in insulin response oGTT	Baseline
Hemoglobin A1c (HbA1c)	Baseline
Change in C peptide over oGTT	Baseline

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States