RightFit
RecruitingPhase 1

Metabolic Effects of Angiotensin-(1-7)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion."
  • "Subjects will receive intravenous angiotensin-(1-7) or saline infusion on two separate study days, with each study day lasting approximately four hours."
  • "On each study day, subjects will be instrumented with two intravenous catheters (one for blood sampling and one for drug infusion), arm and finger blood pressure cuffs, and sticky patches to measure heart rate throughout the study."
  • "The investigators will take baseline measurements of blood pressure and heart rate and collect blood samples."
  • "At the end of 30 minutes, blood samples will be collected and the rebreathing test will be repeated."
  • "The investigators will continue the angiotensin-(1-7) or saline infusion for an additional 2 hours while performing a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether angiotensin-(1-7), given into a vein, helps insulin work better in adults with obesity and insulin resistance. Insulin resistance means the body does not respond well to insulin, which controls blood sugar. The study also checks changes in blood pressure, blood flow, and hormones.

The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 18 to 60, of any sex or race.
  • Body mass index (BMI), a measure of weight based on height, between 30 and 40.
  • Insulin resistance, with a HOMA2-IR test score above 2.2.
  • Blood pressure above 130/85 on at least two seated readings, or taking blood pressure medicine.
  • Able and willing to give informed consent, meaning you understand and agree to join.

Who can't join

  • Pregnant or breastfeeding; currently smoke; previously smoked more than 2 packs a day; or have a history of alcohol or drug abuse.
  • BMI above 40; type 1 or type 2 diabetes, including fasting blood sugar above 126 mg/dL or use of diabetes medicine; or a past allergic reaction to study medicines.
  • Certain heart or blood vessel problems other than high blood pressure, including a heart attack in the past 6 months, heart-related chest pain, serious heart rhythm problems, heart failure, blood clots, or certain heart valve or muscle problems.
  • A history of serious brain blood vessel disease, such as bleeding in the brain, stroke, or a mini-stroke.
  • Immune system or blood disorders; reduced liver or kidney function; or anemia, meaning low levels of the blood protein that carries oxygen.
  • Taking certain medicines: SNRIs or NET inhibitors, which affect nerve chemicals; PDE5 inhibitors, used for erection problems and some lung blood pressure problems; blood thinners; or steroids that affect the whole body for more than 7 days in a row in one month.
  • Use of an experimental drug in the month before the study.
  • Unable to give consent, withdrawing consent, or other health, test, or practical issues that the study doctor thinks would prevent you from finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Males and females of all races between 18 and 60 years of age * Obesity defined as body mass index between 30-40 kg/m2 * Insulin resistance defined as homeostasis model assessment 2 insulin resistance (HOMA2-IR) score \>2.2 * Hypertension defined by two or more properly measured seated blood pressure readings \>130/85 mmHg, or by use of anti-hypertensive medications. This blood pressure cutoff will allow us to include subjects with pre-hypertension. * Able and willing to provide informed consent Exclusion Criteria: * Pregnancy or breast-feeding * Current smokers or history of heavy smoking (\>2 packs/day) * History of alcohol or drug abuse * Morbid obesity (BMI \> 40 kg/m2) * Previous allergic reaction to study medications * Evidence of type I or type II diabetes (i.e. fasting glucose \>126 mg/dl, use of anti-diabetic medications) * Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy * History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack * History or presence of immunological or hematological disorders * Impaired hepatic function \[aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) \> 2.0 x upper limit of normal range\] * Impaired renal function (serum creatinine \>1.5 mg/dl) * Anemia (hemoglobin \<13.5 g/dl in males or \<12.5 g/dl in females) * Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors * Treatment with phosphodiesterase 5 inhibitors * Treatment with anticoagulants * Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) * Treatment with any investigational drug in the 1 month preceding the study * Inability to give, or withdraw, informed consent * Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol)

Study sites (1)

TN