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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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

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

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

Primary study objectives

Resting energy expenditure

Uncoupling protein 1

Secondary study objectives

Blood pressure

Heart rate

Other study objectives

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

0 / 14Eligibility criteria met