Obesity Clinical Trial
Official title:
Atrial Natriuretic Peptide and Regulation of Cardiometabolic Health: A Genotype-Guided Human Physiological Study
Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have ~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have ~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 30, 2027 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265. — View Citation
Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049. — View Citation
Bajaj NS, Gutierrez OM, Arora G, Judd SE, Patel N, Bennett A, Prabhu SD, Howard G, Howard VJ, Cushman M, Arora P. Racial Differences in Plasma Levels of N-Terminal Pro-B-Type Natriuretic Peptide and Outcomes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. JAMA Cardiol. 2018 Jan 1;3(1):11-17. doi: 10.1001/jamacardio.2017.4207. — View Citation
Parcha V, Kalra R, Li P, Oparil S, Arora G, Arora P. Nocturnal blood pressure dipping in treated hypertensives: insights from the SPRINT trial. Eur J Prev Cardiol. 2022 Feb 19;29(1):e25-e28. doi: 10.1093/eurjpc/zwaa125. No abstract available. — View Citation
Parcha V, Patel N, Gutierrez OM, Li P, Gamble KL, Musunuru K, Margulies KB, Cappola TP, Wang TJ, Arora G, Arora P. Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals. J Am Coll Cardiol. 2021 May 11;77(18):2291-2303. doi: 10.1016/j.jacc.2021.03.291. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Primary | Change in Exercise Energy Expenditure between the high genotype and low genotype group. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Primary | Change in miR-425 levels following a standardized oral glucose challenge in those with low ANP genotype. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Primary | Change in miR-425 levels following a standardized exercise challenge in those with low ANP genotype. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the NPs (ANP, BNP, NTproBNP) following the glucose challenge between the high genotype group and low genotype group. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in the serum glucose following the glucose challenge between the high genotype group and low genotype group. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in the serum insulin following the glucose challenge between the high genotype group and low genotype group. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in Resting Energy Expenditure (REE) between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the NPs (ANP, BNP, NTproBNP) with standardized exercise protocol between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the serum glucose levels with standardized exercise protocol between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the serum insulin levels with standardized exercise protocol between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the free fatty acid levels with standardized exercise protocol between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in the glycerol levels with standardized exercise protocol between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following glucose challenge. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in miR-425 levels with change in serum glucose levels following glucose challenge. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in serum insulin levels following glucose challenge. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in serum glucose levels following exercise challenge. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in miR-425 levels with change in serum insulin levels following exercise challenge. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Correlation of resting miR-425 levels with REE | Levels of miR-425 measured in 2-??CT will be assessed and will be related to REE measured in kcal/min | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | |
Secondary | Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following glucose challenge between the two genotype groups. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in miR-425 levels with change in serum glucose levels following glucose challenge between the two genotype groups. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in serum insulin levels following glucose challenge between the two genotype groups. | From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days | ||
Secondary | Change in miR-425 levels with change in serum glucose levels following exercise challenge between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Change in miR-425 levels with change in serum insulin levels following exercise challenge between the two genotype groups. | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days | ||
Secondary | Correlation of resting miR-425 levels with REE between the genotype groups. | Levels of miR-425 levels measured in 2-??CT will be related to the REE measured in kcal/min and will be compared between the genotype groups | About 3 hours on the exercise challenge visit day after consuming study meals for 4 days |
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