SarcoidosisNCT03805633
A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
An observational study of Sarcoidosis and Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis, Diabetes Mellitus
- What is being tested?
- Venous blood sample and Ultrasound of pancreas
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 31 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Type 1 diabetes and/or chronic use of corticosteroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
- Conditions
- Sarcoidosis, Diabetes Mellitus
- Being tested
- Venous blood sample, Ultrasound of pancreas
- Medical subject headings
- Sarcoidosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampleDiagnostic test
Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
Ultrasound of pancreasDiagnostic test
Ultrasound of pancreas will be obtained on all study participants.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis Patients | Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis. Receives: Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas | |
| Diabetes Patients | Patients followed by UAB Endocrinology with diabetes mellitus. Receives: Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas | |
| Sarcoidosis and Diabetes patients | Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus. Receives: Diagnostic Test: Venous blood sample; Diagnostic Test: Ultrasound of pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose during oral glucose tolerance test (oGTT)
Measured: Baseline
Secondary outcomes (3)
Change in C peptide over oGTT
Measured: Baseline
Change in insulin response oGTT
Measured: Baseline
Hemoglobin A1c (HbA1c)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start2 Feb 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Why it stopped: Person working on the trial left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Ovalle, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805633
- Sponsor's protocol ID
- IRB-300000289
- Status last verified
- Dec 2019
- First submitted
- 22 Jan 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03805633
- Acronym / sponsor ID
- IRB-300000289
- Conditions
- Sarcoidosis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Person working on the trial left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis Patients | – | Diagnostic Test: Venous blood sample, Diagnostic Test: Ultrasound of pancreasPatients referred to UAB Pulmonology who are diagnosed with sarcoidosis. |
| Diabetes Patients | – | Diagnostic Test: Venous blood sample, Diagnostic Test: Ultrasound of pancreasPatients followed by UAB Endocrinology with diabetes mellitus. |
| Sarcoidosis and Diabetes patients | – | Diagnostic Test: Venous blood sample, Diagnostic Test: Ultrasound of pancreasPatients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Type 1 diabetes and/or chronic use of corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampleVenous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test. | Diagnostic test | Diabetes Patients, Sarcoidosis Patients, Sarcoidosis and Diabetes patients |
| Ultrasound of pancreasUltrasound of pancreas will be obtained on all study participants. | Diagnostic test | Diabetes Patients, Sarcoidosis Patients, Sarcoidosis and Diabetes patients |
Primary outcome
Change in glucose during oral glucose tolerance test (oGTT)
Time frame: Baseline
3 secondary outcomes
Change in C peptide over oGTT
Time frame: Baseline
Change in insulin response oGTT
Time frame: Baseline
Hemoglobin A1c (HbA1c)
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD)
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose during oral glucose tolerance test (oGTT) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.