N/A
N=210
Physical Health in Midlife: Influences of Adversity and Relationships Over Time
Cardiovascular Disease · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01853332 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Hormonal Levels — 910000; 5.8; 22.8; 171.8 ng/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hormonal Levels |
910000; 5.8; 22.8; 171.8; 820000; 530000 | — |
| PRIMARY Psychosocial Adversity |
3.24; 22.41; 2.47; 1.03 | — |
| PRIMARY Psychosocial Health Risk Factors Correlated With BMI |
0.17; 0.23; -0.17; 0.14; 0.49; 0.45 | — |
| PRIMARY Social Adjustment Scale |
2.47 | — |
| SECONDARY Body Mass Index (BMI) |
30.41 | — |
| SECONDARY Health Risk Factors |
1.33 | — |
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 health
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01853332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.