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Genotype-Guided Diet and Exercise for Cardiometabolic Health

N/A

Recruiting

Led By Pankaj Arora, MD, FAHA

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age more than or equal to 18

Consent to the collection of genetic material

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well natriuretic peptides (hormones produced by the heart) work in people with a genetic variation that causes lower levels of these peptides.

Who is the study for?

This trial is for adults over 18 without a history of severe heart conditions like congestive heart failure, heart attack, or stroke. Participants should not be on insulin therapy but must be willing to follow the study protocol and consent to genetic material collection.

What is being tested?

The GENESIS study is looking at how diet and exercise affect hormones produced by the heart called Natriuretic Peptides (NP), which are linked to cardiometabolic health. It will involve an exercise challenge, glucose challenge, and VO2 max determination.

What are the potential side effects?

Since this trial involves dietary changes and physical challenges rather than medication, side effects may include muscle soreness from exercise or discomfort from dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I agree to provide samples for genetic testing.

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You agree to follow the rules of the study.

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I have never had heart failure, a heart attack, or a stroke.

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I do not take insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Exercise Energy Expenditure between the high genotype and low genotype group.

Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.

Change in miR-425 levels following a standardized exercise challenge in those with low ANP genotype.

+1 more

Secondary study objectives

Change in Resting Energy Expenditure (REE) between the two genotype groups.

Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge between the two genotype groups.

Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge.

+20 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental: Low NP Genotype GroupExperimental Treatment4 Interventions

150 healthy adult participants with low NP genotype will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 5 days. On 5th day, the participants will come in for an exercise challenge test. On 6th day, participants will come in a fasting state and drink 75 gm of oral glucose, followed by blood collection every 8 hours.

Group II: Active Comparator: High NP Genotype GroupExperimental Treatment4 Interventions

50 healthy adult participants with high NP genotype will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 5 days. On 5th day, the participants will come in for an exercise challenge test. On 6th day, participants will come in a fasting state and drink 75 gm of oral glucose, followed by blood collection every 8 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Study diet

2017

N/A

~90

0 / 5Eligibility criteria met