Recruiting

Observational Study

Sponsor:

Ali Chappell

Code:

NCT05950282

Conditions

Insulin Resistance

Polycystic Ovary Syndrome

Hyperinsulinism

Obesity

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Insulin Resistance

Polycystic Ovary Syndrome

Hyperinsulinism

Obesity

Metabolic Syndrome

Study ID

NCT05950282

Start date

Feb 1, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Ali M Chappell, PhD, MS, RD

4092070443research@insara.com

Locations

Lilli Health

Recruiting

Houston, Texas, United States, 77554

Contacts

Ali M Chappell, PhD, MS, RD

8064417275achappell@lillihealth.com

More Information

Sponsor

Ali Chappell

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • PCOS
  • Hyperinsulinemia
  • Insulin Resistance
  • Metabolic Syndrome
  • Obesity
  • Type 2 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Ali Chappell on 2026-05-01.