Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068989
• Other study ID #: 1301011408
• Status: Terminated
• Phase: N/A
• First received: February 19, 2014
• Last updated: September 2, 2016
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital

Exclusion Criteria:

• Patients with prior history of diabetes mellitus

• Elevated admission HbA1c (=6.5%)

• Age >80 years

• Metastatic disease with expected life expectancy of less than 12 months

• Pregnancy or a woman who plans to become pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Stress Hyperglycemia

Locations

Country	Name	City	State
United States	Yale New Haven Hospital St. Raphael Campus	New Haven	Connecticut
United States	Norwalk Hospital	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects with an HbA1c greater than or equal to 6.5%		1 year	No