Glucose HomeostasisHCPGNCT07169591
Postprandial Glucose Handing in Contraceptive and IUD Users
An observational study of Glucose Homeostasis, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Homeostasis
- What is being tested?
- Oral Glucose Tolerance test (75g 2-hour)
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University, Ivor Wynne Centre
Hamilton, Ontario, L8S 4K1
About this study
Official title: Exploring the Effect of Hormonal Contraceptives on Postprandial Glucose Handling in Young Healthy Females
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.
Read the 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 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.
- Conditions
- Glucose Homeostasis
- Being tested
- Oral Glucose Tolerance test (75g 2-hour)
- Keywords
- Glucose, Insulin, Female Health, Hormonal Contraceptive, Intrauterine Device, Oral Contraceptive Pill
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| NAT | Naturally-cycling females Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour) | |
| OCP | Combined oral contraceptive users Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour) | |
| IUD | Hormonal intrauterine device users Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
A 2-hour oral glucose tolerance test will be performed in fasted individuals
Measured: 2 hours
Secondary outcomes (5)
Glucose and lipid metabolites
Peak concentration of whole blood glucose
Measured: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
Insulin
Measured: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
C-peptide
Measured: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
Concentration of total and high-density lipoprotein cholesterols
Measured: Fasting (0 min timepoint)
Glucose and lipid metabolites
Concentration of non-esterified fatty acids (NEFAs)
Measured: Fasting (0 min timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Oct 2025
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose HomeostasisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Bell, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169591
- Sponsor's protocol ID
- 18506
- Acronym
- HCPG
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy, IPD will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Hormonal Contraceptives on Postprandial Glucose Handling in Young Healthy Females
- ClinicalTrials.gov ID
- NCT07169591
- Acronym / sponsor ID
- HCPG / 18506
- Conditions
- Glucose Homeostasis
- Keywords
- Glucose, Insulin, Female Health, Hormonal Contraceptive, Intrauterine Device, Oral Contraceptive Pill
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAT | – | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)Naturally-cycling females |
| OCP | – | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)Combined oral contraceptive users |
| IUD | – | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)Hormonal intrauterine device users |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (17 listed)
- Smoking
- Diabetes, cancer, or other metabolic disorders
- Cardiac or gastrointestinal problems
- Infectious disease
- Barium swallow or nuclear medicine scan in the previous 3 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance test (75g 2-hour)Standard oral glucose tolerance test with blood draws every 15-30 minutes for a 2-hour span | Diagnostic test | IUD, NAT, OCP |
Primary outcome
Glucose tolerance
Time frame: 2 hours
A 2-hour oral glucose tolerance test will be performed in fasted individuals
5 secondary outcomes
Glucose and lipid metabolites
Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
Time frame: Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
Glucose and lipid metabolites
Time frame: Fasting (0 min timepoint)
Glucose and lipid metabolites
Time frame: Fasting (0 min timepoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. To protect participant privacy, IPD will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Homeostasis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten E Bell, Ph.D. (905-525-9140 ext. 24872, bellke3@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.