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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
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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.
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