Natriuretic Peptide Augmentation

Exercise capacity VO2 maximum determination for Diabetes

Q: What medical issues can be addressed through Exercise capacity VO2 maximum determination?

<p>Patients with essential <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a>, left ventricular dysfunction and insufficient response to single-drug therapy can find relief through the use of Exercise capacity VO2 maximum determination.</p>

University of Alabama at Birmingham, Birmingham, AL

Targeting 7 different conditionsExercise capacity VO2 maximum determination +4 morePhase 2RecruitingLed by Pankaj Arora, MD, FAHAResearch 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

Self-identified race/ethnicity as African-American or Black

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment 3 months

Follow Up1 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Study Summary

This trial will test whether a medication can help improve the metabolic health of black individuals by augmenting natriuretic peptide levels.

Eligible Conditions

Diabetes
Cardiovascular Disease
Metabolism
Energy Expenditure
Metabolic Diseases
Natriuretic Peptides
Insulin Resistance

Eligibility Criteria

Inclusion Criteria

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

Select...

You identify yourself as African-American or Black.

Timeline

Screening ~ 3 weeks4 visits

Treatment ~ 3 months3 visits

Follow Up ~ 1 weeks3 visits

Screening ~ 3 weeks

Treatment ~ 3 months

Follow Up ~1 weeks

This trial's timeline: 3 weeks for screening, 3 months for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Natriuretic Hormones

Change in insulin sensitivity after natriuretic peptide augmentation

Secondary outcome measures

Change in HBA1c levels

Change in HDL-C levels

Change in HOMA-IR

+22 more

Other outcome measures

Change in Metabolomic Profile

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacubitril/ValsartanExperimental Treatment4 Interventions

We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.

Group II: ValsartanActive Control4 Interventions

0 / 1Eligibility criteria met

Find a site

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,508 Previous Clinical Trials

2,256,361 Total Patients Enrolled

14 Trials studying Diabetes

1,298 Patients Enrolled for Diabetes

Pankaj Arora, MD, FAHAPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

4 Previous Clinical Trials

884 Total Patients Enrolled

1 Trials studying Diabetes

500 Patients Enrolled for Diabetes

Media Library

Sacubitril (Natriuretic Peptide Augmentation) Clinical Trial Eligibility Overview. Trial Name: NCT04055428 — Phase 2

Diabetes Research Study Groups: Valsartan, Sacubitril/Valsartan

Diabetes Clinical Trial 2023: Sacubitril Highlights & Side Effects. Trial Name: NCT04055428 — Phase 2

Sacubitril (Natriuretic Peptide Augmentation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055428 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues can be addressed through Exercise capacity VO2 maximum determination?

"Patients with essential hypertension, left ventricular dysfunction and insufficient response to single-drug therapy can find relief through the use of Exercise capacity VO2 maximum determination."

Answered by AI

What would be considered a successful outcome from this research?

"This 12-week trial seeks to observe the alteration in insulin sensitivity after natriuretic peptide augmentation. Secondary objectives of this research include tracking changes in fasting insulin levels, HOMA-IR, and adipose tissue mass following pharmacological treatment over a twelve week period."

Answered by AI

Is this clinical trial accepting new participants at the moment?

"As per information published on clinicaltrials.gov, this trial is currently recruiting patients and was first mentioned online in August 2020 with its latest update being recorded the same month two years later."

Answered by AI

How many participants are currently receiving treatment as part of this trial?

"Indeed, the information on clinicaltrials.gov conveys that this medical experiment is presently enrolling individuals. The project was initially posted on August 15th 2020 and lastly revised on August 15th 2022. They are seeking to secure 200 research participants from a solitary institution."

Answered by AI

Are there any health risks associated with determining the maximum oxygen uptake of a patient?

"Our team at Power assigned a score of 2 to the safety of Exercise capacity VO2 maximum determination, as this is a Phase 2 trial. This means there has been some evidence collected in support of its safety but none regarding efficacy."

Answered by AI

Have any other explorations been conducted concerning the ability to exercise as measured by VO2 maximum?

"Currently, eight Phase 3 studies are being conducted on Exercise capacity VO2 maximum determination in Montreal, Quebec. Additionally, a total of 826 clinical centres across the globe have trials running related to this research topic."

Answered by AI