Postprandial Glucose Handing in Contraceptive and IUD Users

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Smoking

Diabetes, cancer, or other metabolic disorders

Cardiac or gastrointestinal problems

Infectious disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: NAT1 intervention
Group B: OCP1 intervention
Group C: IUD1 intervention

Trial outcomes

Primary outcomes

1

Glucose tolerance

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

Time frame
2 hours

Secondary outcomes

1

Glucose and lipid metabolites

Peak concentration of whole blood glucose

Time frame
Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
2

Glucose and lipid metabolites

Insulin

Time frame
Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
3

Glucose and lipid metabolites

C-peptide

Time frame
Timepoints: 0 minute, 15 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute
4

Glucose and lipid metabolites

Concentration of total and high-density lipoprotein cholesterols

Time frame
Fasting (0 min timepoint)

Other outcomes

1

Hormone availability

Concentration of 17b estradiol (endogenous estrogen)

Time frame
Fasting (0 min timepoint)
2

Hormone availability

Concentration of endogenous progesterone

Time frame
Fasting (0 min timepoint)
3

Hormone availability

Concentration of ethinyl estradiol (exogenous estrogen)

Time frame
Fasting (0 min timepoint)
4

Hormone availability

Concentration of levonorgestrel (exogenous progesterone)

Time frame
Fasting (0 min timepoint)

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