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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853332
• Other study ID #: 2008-P000424
• Secondary ID: R01AG032030
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: January 12, 2015
• Start date: January 2009
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review BoardUnited States: National Institute on Aging
• Study type: Observational

Clinical Trial 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

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Judge Baker Children's Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Judge Baker Children's Center, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological Health Risk Markers	Participants will be assessed in two visits, baseline (visit 1) and follow up (visit 2) 2.5 years after baseline. To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.; Metabolic Syndrome Components (MetS).; Both insulin and glucose will be measured.; Adipokines.; Myokines.; Triglycerides and HDL cholesterol will be considered in light of their relevance to CVD.; Proinflammatory markers.; Stress hormones.	2.5 years	No
Primary	To assess how adversity and relationship influences may cumulatively predict midlife physical health outcomes.	Measurements will be obtained during 2 meetings and 4 phone calls over the course of the study (2.5 years). The meetings will be held at the beginning and end of the 2.5 year period. These measurements will be analyzed with the physical health outcomes to determine any possible association between adversity/relationships and physical health outcomes.; Measurements of psychosocial outcomes include in-person and telephone interviews as well as questionnaires to assess: Socioeconomic Status (SES), Adversity: Trauma & Stress, Mental Health & Negative Emotions, Competency and Positive Feelings, and Relationships.	2.5 years	No
Primary	To assess how individual psychosocial dimensions and health risk behaviors are associated with midlife health status.	Measurements will be obtained during 2 meetings and 4 phone calls over the course of the study (2.5 years). The meetings will be held at the beginning and end of the 2.5 year period.; Measurements of psychosocial dimensions (attachment, hostility, depressive symptoms) and health risk behaviors (diet, exercise, substance use) will be analyzed by statistically established methods and their associations with midlife health status as determined by physiological measurements calculated.	2.5 years	No
Primary	To assess the interplay of specific stressful experiences (adversities) and physical health outcomes across a 2.5-year midlife period.	Measurements will be obtained during 2 meetings and 4 phone calls over the course of the study (2.5 years). The meetings will be held at the beginning and end of the 2.5 year period.; Acute and chronic stress will be measured by the Evaluation of Lifetime Stressors (ELS) to assess trauma exposure in childhood and adulthood. Individual competences, beliefs, and positive emotions will be assessed by the Social Adjustment Scale (SAS; assesses global functioning and 5 specific domains of functioning in the preceding 2 months via semi-structured interview). Relationships will be assessed based on couples' interactions, Secure Base Scoring System, Dyadic Adjustment Scale.	2.5 years	No