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RecruitingNCT07169591

Postprandial Glucose Handing in Contraceptive and IUD Users

Exploring the Effect of Hormonal Contraceptives on Postprandial Glucose Handling in Young Healthy Females

Sponsor

McMaster University

Enrollment

54 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Glucose Homeostasis

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria15

  • 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 Criteria17

  • 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.
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Interventions

DIAGNOSTIC_TESTOral Glucose Tolerance test (75g 2-hour)

Standard oral glucose tolerance test with blood draws every 15-30 minutes for a 2-hour span

Locations(1)

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, Canada

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NCT07169591