Investigating fasting insulin and insulin resistance across different demographics
Measuring Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
This study looks at how fasting insulin levels and insulin resistance vary among different groups of people based on age, sex, race, weight, and conditions like PCOS to better understand metabolic health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lilli Health Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05950282 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between fasting insulin levels and the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) in relation to various demographic factors such as age, sex, race/ethnicity, BMI, and the diagnosis of polycystic ovary syndrome (PCOS). By analyzing these variables, the study seeks to uncover potential variations in insulin levels that could provide insights into metabolic health and the risk of insulin-related conditions. The findings may help identify how different factors contribute to insulin dysregulation and metabolic disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older, regardless of sex, from diverse racial and ethnic backgrounds, with varying BMI values, including those with and without a PCOS diagnosis.
Not a fit: Patients under 18 years old or those with other endocrine disorders affecting insulin levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of metabolic health and lead to better management strategies for conditions like insulin resistance and PCOS.
How similar studies have performed: While there have been studies examining insulin resistance and demographic factors, this specific approach focusing on the interplay of multiple variables in a diverse population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Age: Participants aged 18+ years Sex: Both males and females Race/Ethnicity: Participants from diverse racial and ethnic backgrounds BMI: Participants across a range of body mass index (BMI) values PCOS Diagnosis: Participants with and without a confirmed diagnosis of PCOS based on established diagnostic criteria Participants must have completed metabolic testing within one month prior to enrollment, including: * Fasting insulin * Hemoglobin A1c (A1c) * Complete lipid panel * Triglycerides Laboratory testing must be completed through a healthcare provider, an independent laboratory, or by using an Insara Insulin Testing Kit Laboratory values must be obtained following a minimum 8-hour fast Participants must have complete laboratory data for all required measures 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 (e.g., insulin-secreting tumors) Significant recent weight change: Loss of more than 5% of body weight within the previous month Pregnancy or breastfeeding Acute illness or infection within the past 2 weeks Use of medications known to significantly affect insulin or glucose metabolism will be recorded and accounted for in analysis
Where this trial is running
Houston, Texas
- Lilli Health — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ali M Chappell — Insara
- Study coordinator: Ali M Chappell, PhD, MS, RD
- Email: research@insara.com
- Phone: 4092070443
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.