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

NCT05950282 | Recruiting DMC

• 1 other identifier: 2023-0060
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to investigate the levels of Fasting Insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) among individuals with varying characteristics, including age, sex, race/ethnicity, BMI (Body Mass Index), and PCOS (Polycystic Ovary Syndrome) diagnosis. The study population consists of a diverse group of participants referred by healthcare providers and online platforms.

You may qualify if:

• 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

Sponsors & Collaborators

• Ali Chappell: lead

Study Sites (1)

Lilli Health

Houston, Texas, 77554, United States

RECRUITING

Related Links

• Insara Website

MeSH Terms

Conditions

Insulin Resistance; Polycystic Ovary Syndrome; Hyperinsulinism; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus

Study Officials

• Ali M Chappell

  Insara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali M Chappell, PhD, MS, RD

CONTACT

4092070443; research@insara.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Founder and CEO

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)