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GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Sep 30, 2026 → Apr 1, 2027
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Primary completion pushed from Sep 30, 2026 to Apr 1, 2027 Eligibility criteria shortened, about 7 words · Secondary endpoints: details revised at 2 of 23 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 2 of 23 entries
    • Study description revised
    • Publications: details revised at 5 of 5 entries
  2. Primary completion date: Apr 30, 2026 to Sep 30, 2026v10
  3. 2 versions Re-verified since Jul 8, 2024, no change to tracked fieldsv8-v9
  4. Collaborators expanded, about 7 wordsv7 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study description shortened, about 52 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Dec 1, 2027 to Apr 30, 2026 Completion date: Dec 1, 2028 to Apr 30, 2027 · Start date: Jun 1, 2022 to Apr 1, 2022 · Site contact updatedv4 Show 3 more changesShow less
    • Completion date: Dec 1, 2028 to Apr 30, 2027
    • Start date: Jun 1, 2022 to Apr 1, 2022
    • Site contact updated
  3. Study title shortened, about 3 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2023 to Jun 1, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 1, 2023 to Jun 1, 2022
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05216042
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Cardiovascular Diseases, Natriuretic Peptides, Cardiometabolic Diseases, Energy Expenditure, Glucose Metabolism, Exercise, Obesity
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov