Metabolic Effects of Angiotensin-(1-7)

Who is this study for? Patients with obesity
What treatments are being studied? Angiotensin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Cynthia Laws, MS
cynthia.laws@vumc.org
615-421-1994
Time Frame
Start Date: 2016-02
Estimated Completion Date: 2029-12
Participants
Target number of participants: 26
Treatments
Experimental: Angiotensin-(1-7)
Subjects will receive intravenous infusion of three ascending doses of Angiotensin-(1-7). The doses are 4, 8, and 16 ng/kg/min. Each dose will be maintained for 10 minutes. The highest dose of Angiotensin-(1-7) will be maintained for an additional 120 minutes during the hyperinsulinemic-euglycemic clamp, for a total of 150 minutes of infusion.
Placebo_comparator: Saline
Subjects will receive an intravenous infusion of saline that is matched in volume to the Angiotensin-(1-7) study day. The saline infusion will also be maintained for a total of 150 minutes.
Sponsors
Leads: Vanderbilt University

This content was sourced from clinicaltrials.gov