Gene-by-Stress Interactions in Intervention Studies Signi... | NCT03011645

Studies
Gene-by-Stress Interactions in Intervention Studies Significance

NCT03011645

Sponsor

Duke University

Status

Terminated

Last Update Posted

Feb 17, 2020Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Cardiovascular Diseases

Interventions

Ziprasidone
Lorcaserin
Placebo Oral Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2P01HL036587-25	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of participants

Expanded Access Info

Start Date

May 24, 2018Actual

Primary Completion Date

Jan 28, 2020Actual

Completion Date

Jan 28, 2020Actual

First Submitted Date

Jan 4, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ziprasidone	Drug	Given by mouth, single dose of 60 mg.	Ziprasidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Area-Under-the-Curve Glucose		Baseline to 2-hours post OGTT
Matsuda Insulin Resistance Index		Baseline to 2-hours post OGTT

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
William E Kraus, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C092292	ziprasidone
C506658	lorcaserin