ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000858291

Ethics application status

Approved

Date submitted

15/05/2018

Date registered

22/05/2018

Date last updated

21/10/2021

Date data sharing statement initially provided

9/03/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Acute effect of the oral contraceptive pill on glucose regulation

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1214-0302

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Obesity

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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).

Intervention code [1]

Not applicable

Comparator / control treatment

As we will conduct the oral glucose challenge during 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) the women are acting as their own comparator..

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Plasma profile of metabolic biomarkers (e.g, glucose, insulin, C-peptide) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [1]

Baseline (Fasted) - T-15 minutes
Post-prandial - T15 minutes, T30 minutes, T60 minutes, T90 minutes, T120 minutes, T180 minutes, T240 minutes

There is no one primary timepoint as we will look at the area under the curve (AUC).

Primary outcome [2]

Metabolic rate (energy expenditure) measured by indirect calorimetery using an open-circuit ventilated hood system (Quark, Cosmed srl, Rome, Italy).

Timepoint [2]

Baseline (Fasted) - T-45 to T0 minutes
Post-prandial - continuous measurement from T15 minutes to T245 minutes

There is no one primary timepoint as we will look at the area under the curve (AUC).

Secondary outcome [1]

Blood pressure as measured byWelch Allyn ProBP 2400 electronic blood pressure device

Timepoint [1]

Baseline (Fasted) - T-15 minutes
Post-prandial - T60 minutes, T120 minutes, T180 minutes, T240 minutes, T280 minutes

Secondary outcome [2]

Body temperature as measured by tympanic thermometer (Braun Thermoscan Pro 6000)

Timepoint [2]

Baseline (Fasted) - T-45 minutes
Post-prandial- T245 minutes and T280 minutes

Secondary outcome [3]

Appetite (hunger, fullness, ability to eat, comfort and nausea), as measured by Visual Analogue Scales

Timepoint [3]

Baseline (fasted) - T-30 minutes, T-15 minutes, T0 minutes
Post-prandial - T15 minutes, T30 minutes, T60 minutes, T90 minutes, T120 minutes, T180 minutes, T210 minutes, T240 minutes, T280 minutes

Secondary outcome [4]

Energy intake as measured by ad lib consumption of a standardised lunch meal. All food items will be double weighed before and after the lunch meal and dietary analysis software (FoodWorks) will be used to calculate the amount of energy consumed.

Timepoint [4]

T250 minutes

Secondary outcome [5]

Plasma profile of biomarkers of cardiovascular risk (e.g. total cholesterol, triglycerides) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [5]

Baseline (Fasted) - T-15 minutes

Secondary outcome [6]

Plasma profile of inflammatory biomarkers (e.g. CRP, TNF-a) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [6]

Baseline (Fasted) - T-15 minutes

Secondary outcome [7]

Plasma profile of gut peptides/markers of appetite control (e.g. leptin, GLP-1) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [7]

Baseline (Fasted) - T-15 minutes
Post-prandial - T15 minutes, T30 minutes, T60 minutes, T90 minutes, T120 minutes, T180 minutes, T240 minutes

Secondary outcome [8]

Plasma profile of hormones (e.g. cortisol, estrogens, thyroxine) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays.

Timepoint [8]

Baseline (Fasted) - T-15 minutes

Secondary outcome [9]

Heart rate as assessed by chest belt (Garmin).

Timepoint [9]

Baseline (Fasted) - T-45 minutes to T0 minutes
Post-prandial - continuous measurement from T15 minutes to T245 minutes

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key 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

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

A sample size of n=16 was determined to be necessary to detect a significant change (0.5mmol/L) in blood glucose (primary variable) and a within-participant variance in blood glucose of 0.4 mmol/L (SD). The sample size will be increased to n=18 to allow for possible dropouts.
Please see: http://hedwig.mgh.harvard.edu/sample_size/js/js_crossover_quant.html
The sample size provides good power to detect differences in energy expenditure (other primary variable) - 8 participants would be required to detect a 5% increase in energy expenditure between contraceptive pill phases, with a standard deviation of 0.05 kcal/min.

Outcome variables will be assessed using a variety of statistical methods including repeated measures ANOVA, Pearson's correlation testing, and mixed-model linear regression analyses.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/06/2018

Actual

7/06/2018

Date of last participant enrolment

Anticipated

30/12/2018

Actual

16/11/2020

Date of last data collection

Anticipated

5/06/2019

Actual

3/12/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

PO Box 5541,
Wellesley Street,
Auckland 1141

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Jennifer Miles-Chan

Address

Senior Lecturer
School of Biological Sciences
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland Research Office

Address [1]

Level 10, Building 620,
Symonds Street,
Auckland 1010

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disabilities Ethics Committees (Northern A Committee)

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

13/04/2018

Approval date [1]

10/05/2018

Ethics approval number [1]

18/NTA/61

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jennifer Miles-Chan

Address

Senior Lecturer
School of Biological Sciences
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Phone

+64 9 9234322

Fax

j.miles-chan@auckland.ac.nz

Contact person for public queries

Name

Jennifer Miles-Chan

Address

Senior Lecturer
School of Biological Sciences
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Phone

+64 9 9234322

Fax

j.miles-chan@auckland.ac.nz

Contact person for scientific queries

Name

Jennifer Miles-Chan

Address

Senior Lecturer
School of Biological Sciences
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Phone

+64 9 9234322

Fax

j.miles-chan@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All individual participant data collected during the trial, after de-identification, underlying published results only.

When will data be available (start and end dates)?

Availability of the above data will start immediately post-publication. No end date is yet determined.

Available to whom?

Case-by-case basis at the discretion of the primary sponsor.

Available for what types of analyses?

Only to achieve aims in the approved proposal.

How or where can data be obtained?

Access subject to approvals by the primary sponsor, with a requirement to sign approved access
agreement. Dr Jennifer Miles-Chan, the primary sponsor, can be contacted on j.mileschan@
auckland.ac.nz or +64 9 923 4322

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7286	Informed consent form			j.miles-chan@auckland.ac.nz
7287	Ethical approval			j.miles-chan@auckland.ac.nz

Results publications and other study-related documents

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