Skip to main content
Clinical Trials/NCT03805633
NCT03805633
Withdrawn
Not Applicable

A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

University of Alabama at Birmingham1 site in 1 countryStarted: February 2, 2018Last updated:

Overview

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Change in glucose during oral glucose tolerance test (oGTT)

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Change in glucose during oral glucose tolerance test (oGTT)

Time Frame: Baseline

Secondary Outcomes

  • Change in insulin response oGTT(Baseline)
  • Change in C peptide over oGTT(Baseline)
  • Hemoglobin A1c (HbA1c)(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fernando Ovalle

Medical Doctor, Professor

University of Alabama at Birmingham

Study Sites (1)

Loading locations...

Similar Trials