Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/06/2017
Date assigned
27/06/2017
Last edited
27/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 1 Diabetes (T1D) is one of the most common chronic diseases of childhood, causing blood sugar levels to become too high. When children with T1D become teenagers or young adults, managing their diabetes is very important due to risky behaviours like unplanned pregnancies. Most young adults are not aware that there can be complications with both the mother and baby due to diabetes, such as birth malformations. Conception should be planned when the mother has normal blood sugar levels. It is important to provide education, counselling and contraception (methods to prevent pregnancy) in young women both with and without T1D. Contraception usually involves hormones (chemical messengers that control the bodies functions), such as birth control or an implantable medical device. Research is needed to examine what the metabolic effects (how food is processed to energy) of hormonal contraception in teenagers with T1D. Previous research has shown that hyperandrogenism (too much male sex hormones) and inflammation (swelling) are frequent problems in women with T1D. Another consideration in this study is to examine the impact of T1D and the use of contraceptives on telomere length. Telomere is the ending portion of the chromosome (part of the genes that carry out genetic information). Telomere length decreases with advancing age and is shortened in cases of type 2 diabetes. Recently, it was shown that the use of COC in adolescents with polycystic ovary syndrome (a syndrome that affects how a womens ovaries work causing irregular periods and other symptoms) decreases telomere length. Whether telomere length is affected by T1D in young women or by the use of contraceptives in these young women, is unknown. The aim of this study is to examine the impact of different types of contraception on young women with T1D when compared to young women without T1D.

Who can participate?
Young women aged 16 to 25 who have T1D and healthy women aged 16-25 years old.

What does the study involve?
Participants are provided counselling about contraception and pregnancy prevention. They are then offer either a contraceptive pill (taken by mouth) or the implantable rods as birth control methods. Participants are followed up for two years and provide blood samples before taking the contraception and at three, six, 12 and 24 months. The women with T1D and the women without are compared to see how the contraception impacts their metabolic control, bone mass, insulin sensitivity and telomere length.

What are the possible benefits and risks of participating?
Participants may benefit from receiving the contraceptive methods and medical control without cost for them. The only risk of the study is the already reported as well-known possible side effects of hormonal contraception.

Where is the study run from?
1. University of Chile (Chile)
2. Instituto Chilena de Medicina Reproductiva (ICMER) (Chile)

When is the study starting and how long is it expected to run for?
May 2017 to April 2021

Who is funding the study?
Fondecyt (Chile)

Who is the main contact?
Professor Ethel Codner

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ethel Codner

ORCID ID

http://orcid.org/0000-0002-2899-2705

Contact details

Institute of Maternal and Child Research
Casilla 226-3
Santiago
Santiago
8360160
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FONDECYT 1170895

Study information

Scientific title

Metabolic effect of the long-acting reversible contraceptive method (implant) compared to combined oral contraceptive in young women with type 1 diabetes

Acronym

Study hypothesis

Adolescents/young women with T1D receiving hormonal combined oral contraception or a long-acting reversible method (implantable progesterone rod) exhibit a detrimental profile of markers associated with inflammation, insulin resistance, and telomere length compared with healthy non-diabetic young women receiving the same type of contraception. As wel, T1D young women will show lower bone mass than healthy young women.

Ethics approval

IRB of the Servicio Salud Metropolitano Central (SSMC) of the Health Ministry of Chile, 29/05/2017, ref: N°431/2017

Study design

Interventional non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Young women with type 1 diabetes or healthy controls.

Intervention

Healthy participants and participants with T1D (N:40) seeking contraception are recruited. Counseling about contraception and pregnancy prevention is given to both groups of women.

Participants are offered either a combined oral contraceptive pill containing ethinyl estradiol 30 ug/desogestrel 0.15mg, or the implantable rod with etonogestrel, the active metabolite of desogestrel. Both methods are currently available for women of this age group and have been considered as first-line options for young women.

Participants are followed for two years and blood samples are obtained at baseline, three, six, 12, and 24 months.

Intervention type

Drug

Phase

Drug names

Implanon (R) contraceptive implant and desogestrel/ethynil estradiol

Primary outcome measures

1. Inflammatory markers is measured using C-Reactive Protein Levels at baseline, three, six, and 12 months
2. Metabolic control (HbA1c) is measured using HbA1c with DCA-2000 (Siemens) equipment at month three, six, nine and 12
3. Bone Mass is measured using DXA (Lunar Prodigy GE) at baseline, 12 and 24 months
4. Insulin sensitivity is measured using estimated insulin sensitivity index, which includes the measurement of adiponectin and was validated for subjects with and without T1D6 at baseline, three, six, and 12 months
5. Telomere length is measured using blood tests at baseline and at 12 months

Secondary outcome measures

1. Metabolic control will be assessed at 18 and 24 months in women with type 1 diabetes
2. Bone mass DXA (Lunar Prodigy GE) and insulin sensitivity in all the participants is assessed using DXA (Lunar Prodigy GE) and insulin sensitivity index at 24 months of treatment

Overall trial start date

02/05/2017

Overall trial end date

30/04/2021

Reason abandoned

Eligibility

Participant inclusion criteria

T1DM patients:
1. Clinical diagnosis of T1D is clear (patient received treatment with insulin from the time of diagnosis with clinical evidence of severe insulin deficiency).
2. Age: 16-25 years old.
3. Seeking contraception.
4. HbA1c lower than 13%
5. Has not used hormonal contraception for the last three months

Healthy subjects:
1. Age 16-25 years old
2. Seeking contraception
3. Has not used hormonal contraception for the last three months

Participant type

Mixed

Age group

Mixed

Gender

Female

Target number of participants

Based in this meta-analysis of effects of combined oral contraception on PCR levels, the required number of subjects needed to observe differences in is ten young women in each arm of the study. However, the continuation of the implant and combined oral contraception in adolescents after 24 months of use is 77% and 45%, respectively. Therefore, an initial sample size of twenty subjects in each arm is calculated to be sufficient to find differences in C-peptide levels throughout the study.

Participant exclusion criteria

Both groups of subjects (patients with type 1 diabetes and healthy controls):
1. Chronic conditions such as celiac sprue, epilepsy, cardiopulmonary or gastrointestinal conditions are present.
2. Use of steroidal medication.
3. Contraindications for using hormonal contraception (WHO criteria: migraine with aura, prothrombotic problems, etc)

Persons with type 1 diabetes:
1. HbA1c higher than 12.9%
2. Honeymoon period
3. Other type of diabetes

Healthy controls:
1. Menstrual cycle abnormalities according to the American Academy of Pediatrics.

Recruitment start date

01/07/2017

Recruitment end date

30/03/2020

Locations

Countries of recruitment

Chile

Trial participating centre

University of Chile
Institute of Maternal and Child Research (IDIMI) Santa Roa 1234
Santiago
8360160
Chile

Trial participating centre

Instituto Chilena de Medicina Reproductiva (ICMER)
José Victorino Lastarria 29 dp 101
Santiago
8320165
Chile

Sponsor information

Organisation

University of Chile

Sponsor details

Facility of Medicine (Facultad de Medicina)
Av. Independencia 1027
Santiago
8380453
Chile

Sponsor type

University/education

Website

http://www.uchile.cl/investigacion

Funders

Funder type

Research council

Funder name

Fondo Nacional de Desarrollo Científico y Tecnológico

Alternative name(s)

National Fund for Scientific and Technological Development, FONDECYT

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Chile

Results and Publications

Publication and dissemination plan

planned presentation in meetings related to Diabetes and Endocrinology during 2020 and 2021. In addition, publication in a high-impact peer reviewed journal at the end of the study.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Ethel Codner at ecodner@med.uchile.cl

Intention to publish date

31/12/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes