Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

Obesity Clinical Trial

Official title:

Measuring Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950282
• Other study ID #: 2023-0060
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Lilli Health
• Contact: Ali M Chappell, PhD, MS, RD
• Phone: 8064417275
• Email: achappell[@]lillihealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.

Description:

This study aims to investigate the significance of measuring fasting insulin and the homeostatic model assessment of insulin resistance (HOMA-IR) in identifying metabolic health across various demographic and clinical factors. Specifically, the study will examine the influence of age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis on insulin levels and insulin resistance as essential indicators of metabolic dysfunction.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: Participants aged 18+ years.

• 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:

• Age: Participants below 18 years

• 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.

Related Conditions & MeSH terms

• Hyperinsulinism
• Insulin Resistance
• Metabolic Syndrome
• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Lilli Health	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lilli Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Fasting Insulin levels and HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) scores among different groups stratified by age, sex, race/ethnicity, BMI, and PCOS (Polycystic Ovary Syndrome) diagnosis.	The primary objective is to investigate the association between these measures and the specified demographic and clinical factors, providing insights into the variations and potential disparities in insulin resistance across different subgroups.	3 years
Secondary	Identify any significant interactions or relationships between the primary outcomes (Fasting Insulin and HOMA-IR) and the demographic and clinical factors, including age, sex, race/ethnicity, BMI, and PCOS diagnosis.	The secondary outcome measure will provide a comprehensive understanding of how various factors may influence insulin resistance and contribute to its heterogeneity in different populations.	3 years

External Links

•   Lilli Health Website