Gene-by-Stress Interactions in Intervention Studies Significance

Cardiovascular Diseases Clinical Trial

Official title:

Gene-by-Stress Interactions in Intervention Studies Significance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03011645
• Other study ID #: Pro00070047
• Secondary ID: 2P01HL036587-25
• Status: Terminated
• Phase: Phase 1
• Start date: May 24, 2018
• Est. completion date: January 28, 2020

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In Aim 3, 100 subjects who participated in previous studies will be recruited to test the ability of a 5HTR2C agonist (lorcaserin) to increase and antagonist (ziprasidone) to reduce cortisol response to mental and metabolic stress in men carrying the rs6318 C allele and women in the rs6318 CC genotype of 5HTR2C. Lorcaserin is serotonin receptor agonist indicated for use as a weight loss drug. Ziprasidone is an antipsychotic indicated for treatment of bipolar disorder. Subjects will be treated with a single dose of each drug, 1 to 2 weeks apart, followed by a mental stress test and an oral glucose tolerance test with multiple blood draws. Each subject will also receive a placebo drug during one of the study visits.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Ziprasidone
Given by mouth, single dose of 60 mg.
• Lorcaserin
Given by mouth, single dose of 20 mg.
• Placebo Oral Tablet
Given by mouth, single dose.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak blood cortisol during the metabolic stress of an OGTT		Baseline to 3-hours post OGTT
Primary	Change in peak blood cortisol during the metabolic stress of a mental stress test		Baseline to 3-hours post mental stress test
Secondary	Area-Under-the-Curve Glucose		Baseline to 2-hours post OGTT
Secondary	Matsuda Insulin Resistance Index		Baseline to 2-hours post OGTT