Status:
COMPLETED
Physical Health in Midlife: Influences of Adversity and Relationships Over Time
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Judge Baker Children's Center
National Institute on Aging (NIA)
Conditions:
Cardiovascular Disease
Type 2 Diabetes
Eligibility:
All Genders
35-55 years
Brief Summary
The purpose of this study is to determine the effects of individual characteristics, life stresses, and relationships over time on psychosocial outcomes (e.g. marriage, parenting, work) and physical h...
Detailed Description
Research Procedures: If a patient choose to take part in this research study, they will undergo these research procedures: The patient will participate in a total of two meetings and four phone calls...
Eligibility Criteria
Inclusion
- Male and female participants between 35 and 55 years of age.
Exclusion
- (based on interference with key assessments)
- Abnormal hepatic function (liver function tests \>2X upper normal);
- abnormal renal function (creatinine \>1.3 mg/dl);
- conditions/illnesses such as active infection, significant malabsorption/malnutrition, cancer;
- active hormonal disease such as overt hypo/hyperthyroidism, hypogonadism, hyper-cortisolism, or treatment with steroids or growth hormone.
- Known Diabetes Mellitus (DM) and Cardiovascular Disease (CVD) will be screened for by a detailed history and systems review.
- Baseline laboratory analysis with chemistries, CBC, hormone levels, and EKG will be completed.
- Two exceptions will be made to the usual exclusion criteria:
- Original subjects with DM or CVD will not be excluded, since that would result in bias in that sample and loss of opportunity to examine predictors associated with these outcomes.
- Community adults diagnosed with these disorders at the screening visit will be retained and referred for medical treatment as needed. In both groups, those with DM and/or CVD will be followed for psychosocial and relevant biomedical variables, excluding assessments interfered with by CVD and DM relevant medications. Those with DM and CVD will at times be separately analyzed, together with participants who develop these disorders in the years of this new study phase.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01853332
Start Date
January 1 2009
End Date
May 1 2014
Last Update
July 24 2017
Active Locations (1)
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1
Judge Baker Children's Center
Boston, Massachusetts, United States, 02120