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Natriuretic Peptide Hormone
BNP Hormone for Obesity (MENP Trial)
Phase 4
Waitlist Available
Led By Talat A Ikizler, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at end of 240-minute iv infusion (at each study visit). (at study visit 1 and 2, ee will be assessed at baseline and at end of 240-minute intravenous infusion. visits will be separated by at least 14 days.)
Awards & highlights
MENP Trial Summary
This trial will study whether the hormone BNP can increase energy expenditure and help with obesity.
Who is the study for?
This trial is for men and women aged 18-40, either lean (BMI: 18.5 to <25 kg/m2) or obese (BMI ≥30 kg/m2). It's not suitable for those with serious heart, lung, liver, kidney diseases; thyroid issues; diabetes; abnormal blood tests; current pregnancy or breastfeeding; or on certain medications affecting metabolism.Check my eligibility
What is being tested?
The study is testing the effects of a hormone called BNP on energy and fat metabolism in humans. Participants will receive either BNP or a saline placebo to see if BNP can increase energy use and cause 'beiging' of fat tissue—a change that could help treat obesity-related metabolic problems.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site due to recombinant human BNP administration. Since it's being compared with saline (a common placebo), any unique side effects from the actual hormone will be closely monitored.
MENP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at end of 240-minute iv infusion (at each study visit). (at study visit 1 and 2, ee will be assessed at baseline and at end of 240-minute intravenous infusion. visits will be separated by at least 14 days.)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at end of 240-minute iv infusion (at each study visit). (at study visit 1 and 2, ee will be assessed at baseline and at end of 240-minute intravenous infusion. visits will be separated by at least 14 days.)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Resting Energy Expenditure (EE)
Secondary outcome measures
Adipose Tissue Gene Expression of Uncoupling Protein 1 (UCP1)
MENP Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo, then BNPExperimental Treatment2 Interventions
At Study Visit 1, subjects will receive an IV infusion of placebo (control, normal saline) for 240 minutes. After a washout period of at least 2 weeks, subjects then present for Study Visit 2, where they will receive an IV infusion of recombinant human b-type natriuretic peptide (BNP (1-32), nesiritide) for 240 minutes.
Group II: BNP, then placeboExperimental Treatment2 Interventions
At Study Visit 1, subjects will receive an IV infusion of recombinant human b-type natriuretic peptide (BNP (1-32), nesiritide) for 240 minutes. After a washout period of at least 2 weeks, subjects then present for Study Visit 2, where they will receive an IV infusion of placebo (control, normal saline) for 240 minutes.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,401 Total Patients Enrolled
Talat A Ikizler, MDPrincipal InvestigatorTennessee Valley Healthcare System Nashville Campus, Nashville, TN
4 Previous Clinical Trials
77 Total Patients Enrolled
Katherine Neubecker Bachmann, MDPrincipal InvestigatorTennessee Valley Healthcare System Nashville Campus, Nashville, TN
1 Previous Clinical Trials
77 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the study drug nesiritide or phenylephrine.You have serious problems with your lungs, liver, or kidneys.You are currently taking medications that can affect your blood sugar levels, like metformin.You are currently taking medications that affect your energy levels or amphetamines.You have severe fear of enclosed spaces that would make it difficult for you to use the metabolic cart as part of the study.You have a serious heart condition, such as heart failure or atrial fibrillation.You are currently taking or have recently taken glucocorticoids.
Research Study Groups:
This trial has the following groups:- Group 1: BNP, then placebo
- Group 2: Placebo, then BNP
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Metabolism Patient Testimony for trial: Trial Name: NCT03397966 — Phase 4
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