Gene-by-Stress Interactions in Intervention Studies Significance

NCT03011645 | Terminated Phase 1 FDA Drug

• 2 other identifiers: Pro000700472P01HL036587-25
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Change in peak blood cortisol during the metabolic stress of an OGTT

  Baseline to 3-hours post OGTT

• Change in peak blood cortisol during the metabolic stress of a mental stress test

  Baseline to 3-hours post mental stress test

Secondary Outcomes (2)

• Area-Under-the-Curve Glucose

  Baseline to 2-hours post OGTT

• Matsuda Insulin Resistance Index

  Baseline to 2-hours post OGTT

Study Arms (3)

Ziprasidone

ACTIVE COMPARATOR

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

Drug: Ziprasidone

Lorcaserin

ACTIVE COMPARATOR

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

Drug: Lorcaserin

Placebo Oral Tablet

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Ziprasidone DRUG

Given by mouth, single dose of 60 mg.

Also known as: Geodon

Ziprasidone

Lorcaserin DRUG

Given by mouth, single dose of 20 mg.

Also known as: Belviq

Lorcaserin

Placebo Oral Tablet DRUG

Given by mouth, single dose.

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

ziprasidone; lorcaserin

Study Officials

• William E Kraus, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: May 24, 2018
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)