Clinical trial NCT03805633: A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
Official title: A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sarcoidosis
Diabetes Mellitus
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glucose during oral glucose tolerance test (oGTT)
timeFrame: Baseline
Secondary outcomes:
measure: Change in C peptide over oGTT
timeFrame: Baseline
measure: Change in insulin response oGTT
timeFrame: Baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: