NCT05950282 Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
| NCT ID | NCT05950282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ali Chappell |
| Condition | Insulin Resistance |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-02-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ali M Chappell
PRINCIPAL INVESTIGATOR
Insara
Frequently Asked Questions
Who can join the NCT05950282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05950282 currently recruiting?
Yes, NCT05950282 is actively recruiting participants. Contact the research team at research@insara.com for enrollment information.
Where is the NCT05950282 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05950282 clinical trial?
NCT05950282 is sponsored by Ali Chappell. The principal investigator is Ali M Chappell at Insara. The trial plans to enroll 150 participants.