NCT07169591 Postprandial Glucose Handing in Contraceptive and IUD Users
| NCT ID | NCT07169591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Glucose Homeostasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-07 |
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 54 participants in total. It began in 2025-10-01 with a primary completion date of 2026-07.
⚠ 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
Goals: The long-term use of hormonal birth control has been shown to effect glucose handling, or blood sugar regulation, and potentially lead to insulin resistance which increases a person's risk for metabolic diseases such as type 2 diabetes. The goal of this study is to investigate how the body handles glucose, in three groups of young, healthy females: NAT (naturally cycling, or not using hormonal birth control), OCP (taking a birth control pill), and IUD (using an intrauterine device). Objectives: We will investigate if the body's ability to handle glucose differs between these groups. We will also explore if these differences are linked to the levels of primary sex hormones in females, estrogen and progesterone, and if the synthetic versions produced by hormonal birth control have the same negative effect. We will use an oral glucose tolerance test to investigate these potential differences, having participants drink a 75 gram glucose beverage and taking blood samples every 15-30 minutes for a 2-hour timespan. These blood samples will be used to measure glucose and insulin levels in the blood to determine any changes that occur in the body in response to glucose.
Eligibility Criteria
Inclusion Criteria: * Within 18-45 years * BMI between 18.5 and 30.0 kg/m2 * Weight stable for the past 6 months (± 2kg) * VO2peak values within a below average to above average rangea * Fasting blood glucose \<6.0 mMb * Resting blood pressure \<140/90 mmHg NAT females: • Regular menstrual cycle for \> 6 months (defined as a cycle length of 21-35 days) OCP users: * Use of combined OCPs as prescribed for \> 3 months * Second generation levonorgestrel drugs only * Monophasic formulations only (Alesse, Alysena, Audrina, Aviane, Min-Ovral, Ovima, or Portia) IUD users: * Insertion of IUD no fewer than 3 months prior to beginning of study * Hormonal, levonorgestrel-releasing IUD (Kyleena or Mirena) Exclusion Criteria: * Smoking * Diabetes, cancer, or other metabolic disorders * Cardiac or gastrointestinal problems * Infectious disease * Barium swallow or nuclear medicine scan in the previous 3 weeks * Pregnant or breastfeeding * Diagnosis of polycystic ovary syndrome * Endometriosis * Use of emergency contraception (e.g., Plan B) within the previous 3 months NAT females: • Use of any type of hormonal contraceptive in the previous 3 months OCP users: * Not using OCP as prescribed (e.g. missing doses or taking drug inconsistently) * Use of OCP for longer than 3 years. IUD users: * Insertion of Kyleena IUD longer than 2 years. * Insertion of Mirena IUD longer than 4 years.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07169591 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Glucose Homeostasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07169591 currently recruiting?
Yes, NCT07169591 is actively recruiting participants. Contact the research team at bellke3@mcmaster.ca for enrollment information.
Where is the NCT07169591 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT07169591 clinical trial?
NCT07169591 is sponsored by McMaster University. The trial plans to enroll 54 participants.