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Hormone Therapy
Angiotensin-(1-7) for Obesity
Phase < 1
Recruiting
Led By Amy C Arnold, PhD
Research Sponsored by Amy Arnold
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-60 years
Capable of giving informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
Study Summary
This trial will help to understand how the hormone angiotensin-(1-7) affects energy balance in obese people.
Who is the study for?
This trial is for adults aged 18-60 with obesity (BMI of 30-40) who can consent to participate. It's not for those with immune or blood disorders, diabetes, serious heart conditions, liver or kidney issues, pregnant/nursing women, drug/alcohol abusers, current smokers/athletes, or anyone on certain medications.Check my eligibility
What is being tested?
The study tests if the hormone angiotensin-(1-7) increases energy expenditure and promotes heat production in fat tissue among obese individuals. Participants will receive either angiotensin-(1-7) or saline as a control to compare effects.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions at the injection site and changes in blood pressure due to the nature of angiotensin-(1-7). Monitoring will occur for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
I understand the study and can agree to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Resting energy expenditure
Uncoupling protein 1
Secondary outcome measures
Blood pressure
Heart rate
Other outcome measures
Abdominal heat production
Aldosterone
Angiotensin II
+8 moreTrial 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: 2, 4, and 8 ng/kg/min. Each dose will be maintained for 10 minutes, with the highest dose maintained for an additional 90 minutes. The total infusion period is 120 minutes.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive intravenous infusion of saline that is matched in volume to the angiotensin-(1-7). The total infusion period is 120 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?
Amy ArnoldLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Obesity
24 Patients Enrolled for Obesity
Amy C Arnold, PhDPrincipal InvestigatorPennsylvania State University College of Medicine
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either 17 years old or younger, or 61 years old or older.I am a person of any gender or race.My liver tests are more than twice the normal range.I am between 18 and 60 years old.I understand the study and can agree to participate.I am currently pregnant, nursing, or I am postmenopausal.I have anemia.I am currently taking blood thinners.I am unable to understand or decide about participating in this study.People who are professional athletes or have extensive training in sports.You have a fear of closed spaces (like elevators or small rooms).I am not taking medications that affect my energy levels.I have a history of immune or blood disorders.I have not had serious heart or brain blood vessel problems recently.My kidney function is impaired with a creatinine level over 2.0 mg/dl.You have a history of alcohol or drug abuse.I have diabetes as shown by high fasting glucose or I'm on diabetes medication.I have been on steroids for more than a week in the past month.I have difficulty making decisions due to a mental condition.Your body mass index (BMI) is between 30 and 40, which means you are overweight or obese.You are currently smoking cigarettes.You have experienced a significant change in weight, either gaining or losing more than 5% of your body weight in the past 3 months.You cannot have participated in any experimental drug studies within the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Angiotensin-(1-7)
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria that would preclude me from participating in this research?
"We are seeking 30 individuals aged 18-60 with obesity, regardless of gender or race. Specific eligibility requirements include a BMI ranging from 30 to 40 kg/m2."
Answered by AI
What primary uses has Angiotensin-(1-7) been demonstrated to address?
"Angiotensin-(1-7) has become a popular treatment for hemodilution, with additional uses to manage conditions associated with caloric deficiency, potassium depletion and oral rehydration."
Answered by AI
Are there any further investigations investigating the effects of Angiotensin-(1-7)?
"As of today, there are 121 clinical trials investigating Angiotensin-(1-7), with 31 in the third stage. Most of these studies occur in Calgary, Alberta however a total of 798 locations worldwide host research for this medication."
Answered by AI
Is there still the opportunity to sign up for this research endeavor?
"Clinicaltrials.gov confirms that this clinical trial was posted on September 26th of 2019, and has been actively recruiting since the most recent update made to it in June 2nd 2022."
Answered by AI
What is the population size of participants for this clinical experiment?
"Affirmative. Visible on clinicaltrials.gov, this medical study was initially made public on September 26th 2019 and has had its most recent update as of June 2nd 2022. An enrolment goal of 30 participants is established for 1 centre."
Answered by AI
Does this research endeavor consider applicants aged fifty-five or greater?
"This medical trial is looking for individuals aged 18 to 60 who are willing to participate."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Penn State Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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