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Peptide

Angiotensin-(1-7) for Metabolic Effects in High Blood Pressure, Insulin Resistance, Metabolic Syndrome, and Obesity

Phase 1

Recruiting

Led By Italo Biaggioni, MD

Research Sponsored by Vanderbilt University

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

Must not have

Inability to give, or withdraw, informed consent

Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp

Summary

This trial is testing if a drug can improve insulin sensitivity in people with obesity and insulin resistance.

Who is the study for?

This trial is for adults aged 18-60 with obesity (BMI of 30-40), high blood pressure, and insulin resistance but not diabetes. Participants should not be pregnant, breastfeeding, or have a history of serious health issues like heart disease or drug abuse. They mustn't be on certain medications like anticoagulants or antidepressants.

What is being tested?

The study investigates the effects of angiotensin-(1-7) on metabolism in obese individuals with insulin resistance. It involves infusing this peptide to see if it improves insulin sensitivity using a special test called hyperinsulinemic-euglycemic clamp and monitors changes in blood pressure and other related body functions.

What are the potential side effects?

While specific side effects are not listed, potential risks may include reactions at the infusion site, changes in blood pressure, hormonal imbalances, and any unforeseen complications related to the infused peptide.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or decide about participating in this study.

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I am currently taking medication for depression or anxiety.

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I am taking medication for erectile dysfunction.

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I am currently taking blood thinners.

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I have been on long-term steroid treatment for over a week in the past month.

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I am a current smoker or have a history of heavy smoking.

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I have not had a heart attack or serious heart issues in the last 6 months.

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I have had a serious stroke or similar condition.

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My liver tests (AST or ALT) are higher than normal.

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I have a history of immune or blood disorders.

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My BMI is over 40.

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I have diabetes as shown by high blood sugar or I'm on diabetes medication.

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My kidney function is impaired with high creatinine levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp

This trial's timeline: 3 weeks for screening, Varies for treatment, and steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Whole-Body Insulin Sensitivity

Secondary study objectives

Blood Pressure

Cardiac Output

Heart Rate

+2 more

Other study objectives

Adipokines

Aldosterone

Angiotensin Peptides

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Angiotensin-(1-7)Experimental Treatment1 Intervention

Subjects will receive intravenous infusion of three ascending doses of Angiotensin-(1-7). The doses are 4, 8, and 16 ng/kg/min. Each dose will be maintained for 10 minutes. The highest dose of Angiotensin-(1-7) will be maintained for an additional 120 minutes during the hyperinsulinemic-euglycemic clamp, for a total of 150 minutes of infusion.

Group II: SalinePlacebo Group1 Intervention

Subjects will receive an intravenous infusion of saline that is matched in volume to the Angiotensin-(1-7) study day. The saline infusion will also be maintained for a total of 150 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin-(1-7)

2020

Completed Phase 2

~120

0 / 13Eligibility criteria met