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NCT Number: NCT07169591

Postprandial Glucose Handing in Contraceptive and IUD Users

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, L8S 4K1, Canada

Location status: Recruiting

About this study

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 premenopausal females (18-45 years), it is imperative to conduct additional research in this area. Fluctuations in primary sex hormones in females have been shown to modulate risk for developing impaired glucose tolerance, however, research in this area as well as work investigating synthetic versions of these hormones for OCP and IUD users remains unclear. It is crucial to investigate how hormonal contraceptives can alter glucose tolerance in young, otherwise healthy females, and what downstream effects contraceptives could have later in life.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Glucose Tolerance test (75g 2-hour)

Diagnostic Test

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

Primary outcomes

  1. Glucose tolerance

    Time frame: 2 hours

    A 2-hour oral glucose tolerance test will be performed in fasted individuals

Secondary outcomes

  1. Glucose and lipid metabolites

    Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute

    Peak concentration of whole blood glucose

  2. Glucose and lipid metabolites

    Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute

    Insulin

  3. Glucose and lipid metabolites

    Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute

    C-peptide

  4. Glucose and lipid metabolites

    Time frame: Fasting (0 min timepoint)

    Concentration of total and high-density lipoprotein cholesterols

  5. Glucose and lipid metabolites

    Time frame: Fasting (0 min timepoint)

    Concentration of non-esterified fatty acids (NEFAs)

Other outcomes

  1. Hormone availability

    Time frame: Fasting (0 min timepoint)

    Concentration of 17b estradiol (endogenous estrogen)

  2. Hormone availability

    Time frame: Fasting (0 min timepoint)

    Concentration of endogenous progesterone

  3. Hormone availability

    Time frame: Fasting (0 min timepoint)

    Concentration of ethinyl estradiol (exogenous estrogen)

  4. Hormone availability

    Time frame: Fasting (0 min timepoint)

    Concentration of levonorgestrel (exogenous progesterone)

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten E Bell, Ph.D.

CONTACT

[email protected]

905-525-9140 ext. 24872

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: HCPG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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