Gene-by-Stress Interactions in Intervention Studies Significance

• Status: Terminated
• Trial end date: 2020-01-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify gene variants that increase risk of cardiovascular disease (CVD) and type 2 diabetes, particularly genes related to stress factors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Ziprasidone

Criteria

Inclusion Criteria:

• Men and women who have been enrolled in the STRRIDE, ENHANCED, and/or REMIT studies age 18 years or greater.

• Ability and willingness to provide informed consent.

• Individuals with specific genotypes as determined from our previous work on their samples through Aim 1 of this project.

Exclusion Criteria:

• Women who are known to be pregnant, intend to become pregnant, or breast-feeding will be excluded. Women who are of child bearing potential (under age 55) will be informed that they will need to have their urine tested for pregnancy and that they should not participate in the research if they are not willing to have the Investigators provide them with information on positive pregnancy test results. Subjects will be informed that the pregnancy testing is not being performed for clinical purposes and that the testing is not a substitute for their regular medical care if they need to know whether or not they may be pregnant.

• History of Type II diabetes mellitus.

• History of prolonged QT interval.

• Participation in an investigational drug trial within the last 30 days.

• Already taking either ziprasidone or lorcaserin or any potential confounding medications, for example, other weight loss medications or psychotropic medications.

• Unwillingness to fast for at least 6 hours prior to the research study visit.