Recruiting

Glucose Handling

Sponsor:

McMaster University

Code:

NCT07169591

Conditions

Glucose Homeostasis

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Oral Glucose Tolerance test (75g 2-hour)

Study Details

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.

Conditions

Glucose Homeostasis

Study ID

NCT07169591

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Interventions and Outcome Measures

Arms

NAT

Naturally-cycling females

OCP

Combined oral contraceptive users

IUD

Hormonal intrauterine device users

Interventions

Oral Glucose Tolerance test (75g 2-hour)

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

Primary outcome measure

  • Glucose tolerance [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Locations

McMaster University, Ivor Wynne Centre

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

More Information

Sponsor

McMaster University

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Glucose
  • Insulin
  • Female Health
  • Hormonal Contraceptive
  • Intrauterine Device
  • Oral Contraceptive Pill

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-09-22.