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New treatment option for Diabetes Mellitus
Official title NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
ClinicalTrials.gov ID: NCT04055428
What this study is testing
What is Sacubitril, Valsartan 97-103 mg Oral Tablet?
Sacubitril, Valsartan 97-103 mg Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for diabetes mellitus.
Also referred to as Sacubitril/Valsartan arm.
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
- Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adults: Age more than or equal to 18 years of age
- Self-identified race/ethnicity as African-American or Black
- Blood pressure: 120-160/80-100 mmHg
You likely can't join if
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study...
- Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or...
- BP more than 160/100 mmHg
- BMI \>45 kg/m2
- History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5%
- History of angioedema
See the full eligibility criteria
- Adults: Age more than or equal to 18 years of age
- Self-identified race/ethnicity as African-American or Black
- Blood pressure: 120-160/80-100 mmHg
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
- Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
- BP more than 160/100 mmHg
- BMI \>45 kg/m2
- History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5%
- History of angioedema
- Current or past (\<12 months) history of smoking
- Estimated GFR \< 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
- Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
- Significant psychiatric illness or seizure disorder
- More than 2 Alcoholic drinks daily
- Anemia (men, Hct \< 38%, Hb\<13 g/dL; women, Hct \<36%, Hb \<12 g/dL)
- Inability to exercise on a treadmill
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, 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 - 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.