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NCT02068989 Clinical Trial

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
Secondary ID
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

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
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