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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
Must not have
Age ≤ 17 or ≥ 61 years
Impaired hepatic function (aspartate aminotransferase or alanine aminotransferase levels >2 times upper limit of normal range)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

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 below
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I am between 18 and 60 years old.
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I understand the study and can agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am either 17 years old or younger, or 61 years old or older.
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My liver tests are more than twice the normal range.
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I am currently pregnant, nursing, or I am postmenopausal.
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I am currently taking blood thinners.
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I am unable to understand or decide about participating in this study.
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I am not taking medications that affect my energy levels.
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I have a history of immune or blood disorders.
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I have not had serious heart or brain blood vessel problems recently.
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My kidney function is impaired with a creatinine level over 2.0 mg/dl.
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I have diabetes as shown by high fasting glucose or I'm on diabetes medication.
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I have been on steroids for more than a week in the past month.
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I have difficulty making decisions due to a mental condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

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 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: 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
8 Total Patients Enrolled
1 Trials studying Obesity
8 Patients Enrolled for Obesity
Amy C Arnold, PhDPrincipal InvestigatorPennsylvania State University College of Medicine
2 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Angiotensin-(1-7) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03777215 — Phase < 1
Obesity Research Study Groups: Placebo, Angiotensin-(1-7)
Obesity Clinical Trial 2023: Angiotensin-(1-7) Highlights & Side Effects. Trial Name: NCT03777215 — Phase < 1
Angiotensin-(1-7) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03777215 — Phase < 1
~2 spots leftby Dec 2024