Postprandial Glucose Handing in Contraceptive and IUD Users

NCT07169591 | Recruiting

• 1 other identifier: 18506
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance

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

  2 hours

Secondary Outcomes (5)

• Glucose and lipid metabolites

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

• Glucose and lipid metabolites

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

• Glucose and lipid metabolites

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

• Glucose and lipid metabolites

  Fasting (0 min timepoint)

• Glucose and lipid metabolites

  Fasting (0 min timepoint)

Other Outcomes (4)

• Hormone availability

  Fasting (0 min timepoint)

• Hormone availability

  Fasting (0 min timepoint)

• Hormone availability

  Fasting (0 min timepoint)

Study Arms (3)

NAT

Naturally-cycling females

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

OCP

Combined oral contraceptive users

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

IUD

Hormonal intrauterine device users

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

Interventions

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

IUD; NAT; OCP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 54 young healthy recreationally active females (n=18 per group) 18-45 years of age from the following groups: 1) individuals currently taking second generation OCPs containing levonorgestrel, 2) individuals with a levonorgestrel-releasing IUD, and 3) NAT individuals.

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Kirsten E Bell, Ph.D.

CONTACT

905-525-9140; bellke3@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)