Contraception in type 1 diabetes

• Register: ISRCTN
• Last refreshed on: 12 February 2024
• Main ID: ISRCTN29256651
• Date of registration: 27/06/2017
• Prospective Registration: Yes
• Primary sponsor: University of Chile
• Public title: Contraception in type 1 diabetes
• Scientific title: Metabolic effect of the long-acting reversible contraceptive method (implant) compared to combined oral contraceptive in young women with type 1 diabetes
• Date of first enrolment: 01/07/2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN29256651
• Study type: Interventional
• Study design: Interventional non randomised study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Chile

Contacts

• Name: Ethel Codner

Key inclusion & exclusion criteria

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

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.


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Young women with type 1 diabetes or healthy controls.
Nutritional, Metabolic, Endocrine
Type 1 diabetes

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

FONDECYT 1170895

Source(s) of Monetary Support

Fondo Nacional de Desarrollo Científico y Tecnológico

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/04/2021