A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Diabetes Clinical Trial

— NOD  

Official title:

A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03731637
• Other study ID #: 17-011305
• Secondary ID: U01DK108328A2117
• Status: Active, not recruiting
• Start date: October 15, 2018
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).

Description:

A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 5 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for NOD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2270
• Est. completion date: June 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject is able and willing to provide informed consent and sign an informed consent form.

• Subject must sign an authorization for the release of their protected health information.

• Subject must be =50 and =85 years of age at the time of enrollment.

• Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:

• All glycemic parameters must be measured in an outpatient setting

A. (1) Hemoglobin A1c (HbA1c) = 6.5% present, OR

B. Any (2) PDMs present on consecutive or simultaneous testing:

• Fasting Blood Glucose (FBG) =126 mg/dl

• Hemoglobin A1c (HbA1c) = 6.5%

• Random Blood Glucose (RBG) =200 mg/dl

• 2h Post Glucose (PG) =200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test), OR

C. Any (1) PDM present followed by an anti-diabetes medication

• Subject must have >1 glycemic parameter measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.

• Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.

• Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

• Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

• Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.

• Subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

• Ongoing work up for suspicion of pancreatic cancer is not an exclusion.

• Subject must not have any past history of pancreatic cancer.

• Subject must not be on anti-diabetes medications prior to the elevated index lab.

• Subject must not be on chronic or acute use of steroid medications within 90 days of the elevated index lab.

• Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

• Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.

• In the physician's and/or investigator's judgement, subject does not have any co-morbidities that limit the subject's participation in the study.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type2 Diabetes

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Univeristy Hospital, Indian University Health	Indianapolis	Indiana
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Greater Los Angeles Veterans Affairs Medical Center	Los Angeles	California
United States	Kaiser Permanente Southern California	Los Angeles	California
United States	Marshfield Clinic Health System	Marshfield	Wisconsin
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Kaiser Permanente Northern California	Oakland	California
United States	Advent Health Translational Research Institute	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Gibbs Cancer Center & Research Institute	Spartanburg	South Carolina
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Trinity Health Ann Arbor Hospital	Ypsilanti	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	Alliance for Clinical Trials in Oncology, M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007. — View Citation

Setiawan VW, Stram DO, Porcel J, Chari ST, Maskarinec G, Le Marchand L, Wilkens LR, Haiman CA, Pandol SJ, Monroe KR. Pancreatic Cancer Following Incident Diabetes in African Americans and Latinos: The Multiethnic Cohort. J Natl Cancer Inst. 2019 Jan 1;111 — View Citation

Sharma A, Smyrk TC, Levy MJ, Topazian MA, Chari ST. Fasting Blood Glucose Levels Provide Estimate of Duration and Progression of Pancreatic Cancer Before Diagnosis. Gastroenterology. 2018 Aug;155(2):490-500.e2. doi: 10.1053/j.gastro.2018.04.025. Epub 2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes	Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset hyperglycemia and diabetes.	3 years
Primary	Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes	We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing.	3 years

External Links

•   Mayo Clinic Clinical Trials