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Acute effect of the oral contraceptive pill on glucose regulation

Acute effect of the oral contraceptive pill on glucose homeostasis in healthy women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000858291
Enrollment
21
Registered
2018-05-22
Start date
2018-06-07
Completion date
2020-11-16
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The prevalence of cardiometabolic disease is increasing worldwide, and particularly amongst young women. Furthermore, the risk posed by these diseases appears to differ between the sexes, with type 2 diabetes conferring higher risk cardiovascular related mortality in women. However our understanding of how sex hormone status influences glucose handling is limited. Moreover, despite decades of consumption, surprisingly little conclusive research has been conducted on the effects of exogenous sex hormones (such as those contained within the oral contraceptive pill) on this relationship. This project will shed light on the relationship between exogenous hormones and glucose handling by examining the acute effects that oral contraceptives have on glucose homeostasis and metabolic profile in women of child bearing age. Oral contraceptives are known to regulate the menstrual cycle by the use of exogenous hormones, containing 21 days of active (hormonal) pills, and 7 days of inactive (placebo) pills. This study will recruit 18 women on the combined oral contraceptive pill. The women will be between 20 and 40 years of age, and have a “normal” BMI (18.5 -24.9 kgm-2). These women will undergo testing at the end of both the hormonal pill phase and the inactive pill phase to determine whether there are differences in glucose homeostasis and metabolic profile as a result of exogenous hormone use. An oral glucose tolerance test will be conducted during each phase, along with concomitant monitoring of energy expenditure and substrate utilisation (by indirect calorimetry), body temperature, and metabolic profiling in blood. The results gained from this study will be of importance not only to our understanding of the relationship between the combined oral contraceptive pill on glucose homeostasis, but also in terms of the optimisation of standards of care for treatment of diabetes, with the ultimate aim of tailoring diabetes treatment/prevention strategies in accordance with hormonal status to their efficacy.

Interventions

We will conduct a study of 18 New Zealand healthy women (18 – 40 years old, normal BMI). These women will be regular users of the monophasic combined oral contraceptive pill. We will measure metabolic response to an oral glucose challenge of 60g of glucose dissolved in 490ml water + 10ml of lemon juice administered after a 12 hour fast (water allowed) during both phases of contraceptive pill use (once during the 21 days of hormone-containing pills, and once during the 7 days of non-hormone (sug

We will conduct a study of 18 New Zealand healthy women (18 – 40 years old, normal BMI). These women will be regular users of the monophasic combined oral contraceptive pill. We will measure metabolic response to an oral glucose challenge of 60g of glucose dissolved in 490ml water + 10ml of lemon juice administered after a 12 hour fast (water allowed) during both phases of contraceptive pill use (once during the 21 days of hormone-containing pills, and once during the 7 days of non-hormone (sugar) pills).

Sponsors

Dr Jennifer Miles-Chan
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Provision of informed consent Female  Aged 18­-40 years BMI 18.5 - 24.9 kg/m2 Self­ reported healthy Combined monophasic oral contraceptive pill use for >3 months Self-reported with regular menses.

Exclusion criteria

Pregnancy or breastfeeding History of chronic disease Use of any medication other than the oral contraceptive pill during the last 3 months Vegetarian Claustrophobia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026