Gene-by-Stress Interactions in Intervention Studies Significance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2020-01-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ziprasidone

Ziprasidone 60 mg tablet by mouth, once a day for one day.

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

Given by mouth, single dose of 60 mg.

Lorcaserin

Lorcaserin 20 mg tablet by mouth, once a day for one day.

Group Type ACTIVE_COMPARATOR

Lorcaserin

Intervention Type DRUG

Given by mouth, single dose of 20 mg.

Placebo Oral Tablet

Sugar pill (in place of ziprasidone and lorcaserin) by mouth, once a day for one day.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Given by mouth, single dose.

Interventions

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Ziprasidone

Given by mouth, single dose of 60 mg.

Intervention Type DRUG

Lorcaserin

Given by mouth, single dose of 20 mg.

Intervention Type DRUG

Placebo Oral Tablet

Given by mouth, single dose.

Intervention Type DRUG

Other Intervention Names

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Geodon Belviq

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No