Status:
RECRUITING
Postprandial Glucose Handing in Contraceptive and IUD Users
Lead Sponsor:
McMaster University
Conditions:
Glucose Homeostasis
Eligibility:
FEMALE
18-45 years
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 ...
Detailed Description
Insulin resistance is a common metabolic condition, and is considered a primary risk factor for the development of type 2 diabetes (T2D). As the prevalence of T2D continues to rise, particularly among...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07169591
Start Date
October 1 2025
End Date
October 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
McMaster University, Ivor Wynne Centre
Hamilton, Ontario, Canada, L8S 4K1