Physical Health in Midlife: Influences of Adversity and Relationships Over Time



Status:Recruiting
Conditions:Peripheral Vascular Disease, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:35 - 55
Updated:2/7/2015
Start Date:January 2009
Contact:Cynthia R Davis, PhD
Email:crdavis@jbcc.harvard.edu

Use our guide to learn which trials are right for you!

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

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 over the course
of the study (two and a half years). The meetings will be held at the beginning and end of
the two and a half year period. The first part of each meeting will take place at Beth
Israel Deaconess Medical Center (BIDMC) where they will sign this consent form and then be
interviewed for medical history, given a physical examination, and have blood tests
described below. The patient will then be transported to Judge Baker Children's Center
(JBCC), where they will have lunch, complete questionnaires, and participate in taped
interviews (approximately 4 hours). The phone calls will be approximately every six months
and the patient will be contacted by the people at JBCC. More detailed information on the
study procedures is outlined below and on the JBCC consent form for the study.

Interviews, Questionnaires, and Phone calls: These aspects of the study are covered in the
Judge Baker Children's Center consent form. Briefly, the patient will be asked to discuss
relationships with their partner, family, and friends, their career, their current goals in
life, their health status, etc. These sessions will be recorded so that the patient's
answers can be coded and analyzed at a later time. All information will be kept strictly
confidential.

Medical Examination: The patient will arrive fasting to the medical examination. During the
medical exam, a physician will ask the patient questions about their physical health and
family history. The doctor will then conduct a physical examination which includes:

1. Glucose finger stick for diabetes screening

2. Vital signs (such as blood pressure) and anthropometrics (such as waist circumference).

3. Measuring the amount of fat in the patient's body using bioelectrical impedance
analysis. This test will measure the resistance to the naturally occurring flow of
electrical currents within the nerves and muscles using a few electrical sensors
(similar to the EKG) attached to the patient's wrist and ankle for less than a minute.
This procedure is not painful and uses the same principle as weighing oneself on a
scale that provides body mass index.

4. Measuring the patient body's ability to use sugar through an oral glucose tolerance
test (OGTT). A nurse will place an intravenous (IV) catheter (a small tube) in the
patient's arm. It will be taped to stay in place for approximately four hours. The
patient will drink a mixed nutrient drink called Boost. The patient's blood will be
drawn through the catheter 15 min after the Boost is given and then at 30-minute
intervals for 3 hours to measure how they metabolize the nutrient drink.

5. EKG

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:

1. 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.

2. 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.
We found this trial at
1
site
Boston, Massachusetts 02120
?
mi
from
Boston, MA
Click here to add this to my saved trials