Recruiting

Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

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.

ClinicalTrials.gov IDNCT05950282
PhaseNot Applicable
Enrollment150
SponsorAli Chappell
Age18 Years and older
SexALL
I'm interested View official listing

Conditions studied

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

About this study

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.

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-07.