Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
NCT ID: NCT05950282
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-02-01
2026-12-31
Brief Summary
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Detailed Description
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Metabolic health disorders, such as insulin resistance and impaired glucose metabolism, are known to be associated with an increased risk of developing conditions like type 2 diabetes, cardiovascular diseases, and metabolic syndrome. Traditionally, glucose levels have been used to assess metabolic health; however, fasting insulin and HOMA-IR provide valuable insights into the underlying insulin dysregulation that precedes the onset of these conditions.
Disparities in insulin levels have been observed across different racial and ethnic groups. These variations may arise from genetic predispositions, differences in lifestyle, or a combination of both, thus highlighting the need to explore these factors comprehensively. BMI, a measure of body composition, has been strongly associated with elevated insulin levels and insulin resistance. Individuals with obesity often exhibit dysregulated insulin metabolism, leading to higher fasting insulin and HOMA-IR values. Furthermore, PCOS, a common endocrine disorder affecting reproductive-age women, is frequently associated with insulin resistance. Studying the insulin profiles among women with PCOS will shed light on the potential metabolic implications and help tailor interventions for this at-risk population.
The study will employ a cross-sectional design, enrolling a large sample of participants from diverse backgrounds. Fasting insulin levels will be measured using standardized laboratory methods, and HOMA-IR scores will be calculated based on fasting insulin and glucose values. Statistical analyses, including regression models and subgroup comparisons, will be conducted to assess the associations between fasting insulin, HOMA-IR, and the demographic and clinical factors of interest.
This research aims to emphasize the importance of incorporating fasting insulin and HOMA-IR measurements alongside glucose assessments to enhance the identification and understanding of metabolic health disorders. The findings are expected to contribute to a more comprehensive approach in diagnosing, managing, and preventing metabolic diseases, ultimately leading to improved patient outcomes and public health interventions.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Sex: Both males and females.
* Race/Ethnicity: Participants from diverse racial and ethnic backgrounds
* BMI: Participants with a range of body mass index (BMI) values
* PCOS Diagnosis: Participants with and without a confirmed diagnosis PCOS based on established diagnostic criteria.
Exclusion Criteria
* Sex: None. Both males and females are included.
* Race/Ethnicity: None. Participants from all racial and ethnic backgrounds are included.
* Endocrine Disorders: Participants with other endocrine disorders affecting insulin levels, such an insulin secreting tumor.
18 Years
ALL
No
Sponsors
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Lilli Health
OTHER
Responsible Party
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Ali Chappell
Founder and CEO
Principal Investigators
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Ali M Chappell
Role: PRINCIPAL_INVESTIGATOR
Lilli Health
Locations
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Lilli Health
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Lilli Health Website
Other Identifiers
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2023-0060
Identifier Type: -
Identifier Source: org_study_id
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