Obesity study: Angiotensin- vs Saline
Official title Metabolic Effects of Angiotensin-(1-7)
ClinicalTrials.gov ID: NCT02646475
What this study is testing
What is Angiotensin-(1-7)?
This is an investigational peptide being studied to see if it helps with insulin resistance in people with obesity. It is designed to dilate blood vessels and may help regulate how the body uses insulin.
Also referred to as Angiotensin I (1-7).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if angiotensin‑(1‑7) can improve how the body uses insulin and affect blood pressure in people who are obese and have insulin resistance.
- Who it's for
- Adults who are obese and have insulin resistance.
- What's involved
- Participants will receive infusions of angiotensin‑(1‑7) and have blood tests and a special insulin sensitivity test (hyperinsulinemic‑euglycemic clamp) to measure changes.
- Time commitment
- The study lasts a few weeks and includes several clinic visits for infusions, blood draws, and the insulin sensitivity test.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
- Able and willing to provide informed consent
You likely can't join if
- 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)
See the full eligibility 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.
- Able and willing to provide informed consent
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.