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

Status Completed

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

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Type 2 Diabetes

• NCT number: NCT01853332
• Study type: Observational
• Source: Beth Israel Deaconess Medical Center
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Completion date: May 2014