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A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03805633
Enrollment
0
Registered
2019-01-16
Start date
2018-02-02
Completion date
2020-01-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis, Diabetes Mellitus

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.

Interventions

DIAGNOSTIC_TESTVenous blood sample

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

DIAGNOSTIC_TESTUltrasound of pancreas

Ultrasound of pancreas will be obtained on all study participants.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Change in glucose during oral glucose tolerance test (oGTT)Baseline

Secondary

MeasureTime frame
Change in C peptide over oGTTBaseline
Change in insulin response oGTTBaseline
Hemoglobin A1c (HbA1c)Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026