Trial record 10 of 199 for:    Open Studies | "Hyperglycemia"

Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02068989
First received: February 19, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068989

Contacts
Contact: Anu Sharma, MBBS 2036801560 anu.sharma@yale.edu
Contact: Stephen Atlas, MD 2037893103 stephen.atlas@ynhh.org

Locations
United States, Connecticut
Yale New Haven Hospital St. Raphael Campus Recruiting
New Haven, Connecticut, United States, 06511
Contact: Anu Sharma, MBBS    203-680-1560    anu.sharma@yale.edu   
Sub-Investigator: Anu Sharma, MBBS         
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06850
Contact: Jonathon Fine, MD       jonathon.fine@norwalkhealth.org   
Principal Investigator: Jonathon Fine, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Stephen Atlas, MD Yale New Haven Health System Center for Healthcare Solutions
Principal Investigator: Jonathon Fine, MD Norwalk Hospital
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02068989     History of Changes
Other Study ID Numbers: 1301011408
Study First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014