Postprandial Glucose Handing in Contraceptive and IUD Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Glucose Tolerance test (75g 2-hour).
- Who it may be relevant to
- Registry conditions: Glucose Homeostasis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring the Effect of Hormonal Contraceptives on Postprandial Glucose Handling in Young Healthy Females
Overview
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.
Interventions
- Diagnostic test 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 measures
- Glucose tolerance [Time frame: 2 hours]
Secondary outcome measures (5)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- McMaster University, Ivor Wynne Centre — Hamilton
Identifiers
NCT: NCT07169591 · 18506