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Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02068989
First Posted: February 21, 2014
Last Update Posted: September 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
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.

Condition
Stress Hyperglycemia Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percentage of Subjects with an HbA1c greater than or equal to 6.5% [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Enrollment: 1
Study Start Date: February 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stress Hyperglycemic Group
Repeat HbA1C in 1 year
Euglycemic Group
Repeat HbA1C in 1 year

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive Care Unit admissions who are not known to be diabetic
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068989


Locations
United States, Connecticut
Yale New Haven Hospital St. Raphael Campus
New Haven, Connecticut, United States, 06511
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Stephen Atlas, MD Yale New Haven Hospital
Principal Investigator: Jonathon Fine, MD Norwalk Hospital
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02068989     History of Changes
Other Study ID Numbers: 1301011408
First Submitted: February 19, 2014
First Posted: February 21, 2014
Last Update Posted: September 5, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases