Physical Health in Midlife: Influences of Adversity and Relationships Over Time
Completed
Conditions studied: Cardiovascular Disease, Type 2 Diabetes
In brief
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 health
Key facts
- Study ID
- NCT01853332
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 210
- Starts
- 2009-01-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2017-07-24
Who can join
Age: 35 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female participants between 35 and 55 years of age.
- Exclusion Criteria: (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.
Where it is running
- Judge Baker Children's Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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