Genotype-guided approach to improve cardiometabolic health using natriuretic peptides
Atrial Natriuretic Peptide and Regulation of Cardiometabolic Health: A Genotype-Guided Human Physiological Study
This study is testing if a special approach using natriuretic peptides can help improve heart and metabolic health in adults with a certain genetic variant that leads to lower levels of these peptides.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05216042 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of natriuretic peptides (NPs) in regulating cardiometabolic health, particularly in individuals with genetically lower NP levels. It focuses on understanding how exercise and glucose challenges affect NP responses in adults who carry a specific genetic variant associated with lower NP levels. The study aims to explore the metabolic benefits of NPs and their potential to mitigate risks associated with cardiovascular diseases and diabetes. Participants will undergo dietary assessments, exercise capacity evaluations, and challenges to assess their metabolic responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who consent to genetic material collection and are willing to adhere to the study protocol.
Not a fit: Patients with a history of cardiovascular diseases, diabetes, or those with severe obesity (BMI > 45 kg/m2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing cardiometabolic health in individuals with low natriuretic peptide levels.
How similar studies have performed: Previous studies have indicated the importance of natriuretic peptides in metabolic health, suggesting that this approach may yield beneficial insights, although the specific genetic focus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults: Age more than or equal to 18; an equal number of Males and Females * Consent to the collection of genetic material * Willing to adhere to the study protocol Exclusion Criteria: * Age \<18, at screening. * BMI \>45 kg/m2. * Blood pressure more than 140/90 mmHg. * Participants who are taking more than 2 hypertension medications. * History of diabetes or fasting plasma glucose \>126 mg/dl or HbA1C\>=6.5% or prior treatment with antidiabetic medication. * Have any past or present history of cardiovascular diseases (stroke, seizure, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia) * 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); * 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 * Anemia (men, Hct \< 38%; women, Hct \<36%) * Inability to exercise on a treadmill
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Pankaj Arora, MD, FAHA — University of Alabama at Birmingham
- Study coordinator: Nehal Vekariya, MS
- Email: nvekariya@uabmc.edu
- Phone: 205-934-7173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.