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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole-Body Insulin Sensitivity
Secondary outcome measures
Blood Pressure
Cardiac Output
Heart Rate
+2 more
Other outcome measures
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

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,143,328 Total Patients Enrolled
7 Trials studying Metabolic Syndrome
393 Patients Enrolled for Metabolic Syndrome
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University
Vanderbilt University
28 Previous Clinical Trials
1,435 Total Patients Enrolled

Media Library

Angiotensin-(1-7) (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT02646475 — Phase 1
Metabolic Syndrome Research Study Groups: Angiotensin-(1-7), Saline
Metabolic Syndrome Clinical Trial 2023: Angiotensin-(1-7) Highlights & Side Effects. Trial Name: NCT02646475 — Phase 1
Angiotensin-(1-7) (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02646475 — Phase 1

Frequently Asked Questions

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

To what extent is Angiotensin-(1-7) a hazard to human health?

"Due to the limited evidence suggesting Angiotensin-(1-7)'s safety and efficacy, our team has assigned a score of 1 on this scale."

Answered by AI

What is the aggregate population of participants signing up for this research?

"Affirmative, the clinicaltrials.gov portal reveals that recruitment is currently underway for this study which was initially posted on February 1st 2016 and has since been updated January 18th 2022. 19 volunteers are required to take part at just one centre."

Answered by AI

What condition typically warrants prescription of Angiotensin-(1-7)?

"Angiotensin-(1-7) is often prescribed for hemodilution, and has further been known to potentially remedy conditions such as a lack of caloric intake, potassium deficiency, or oral rehydration therapy."

Answered by AI

Is there an opportunity to join this experiment at the present time?

"According to the data hosted on clinicaltrials.gov, this medical trial is now recruiting patients after being initially posted in February 2016 and edited most recently in January 2022."

Answered by AI

Are there any previous research projects on the subject of Angiotensin-(1-7)?

"Currently, 124 trials are exploring Angiotensin-(1-7), of which 33 have reached Phase 3. In Calgary, Alberta alone there are several sites dedicated to this research but 867 locations worldwide offer studies on the subject."

Answered by AI

Is the age threshold for participants under 75 years old in this medical experiment?

"As per the inclusion criteria, patients aged 18 to 60 are eligible for this research. In comparison, there are 289 trials that involve minors and 1466 studies targeting adults over 65 years of age."

Answered by AI

Could I potentially join the research project?

"The trial is open to 19 participants aged 18-60 who possess a diagnosis of obesity, defined by a body mass index between 30-40 kg/m2. It is also required that they have an elevated homeostatic model assessment 2 insulin resistance (HOMA2-IR) score greater than 2.2 and are not restricted in regards to gender or race."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Metabolic Effects of Angiotensin-(1-7)
Italo Biaggioni 2016. "Metabolic Effects of Angiotensin-(1-7)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02646475.
All > Blood Pressure > Hypertension
~5 spots leftby Dec 2026
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