SweMaMi DMI, Microbiome

Type 1 Diabetes Clinical Trial

Official title:

SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04346524
• Other study ID #: DM1
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Karolinska Institutet
• Contact: Eva Wiberg-Itzel, PhD
• Phone: +46708775346
• Email: eva.itzel[@]telia.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis. Increased knowledge of the microbiome and its variation, depending on the state of health during pregnancies complicated with type 1 diabetes, could in the future lead to preventive care and treatments during these pregnancies.

Description:

Prospective cohort. All women with type 1 diabetes that are planning a pregnancy and being cared for at the diabetic ward at Södersjukhuset will be asked to participate, n= 55.

All pregnancies complicated with type 1 diabetes that are being cared for at the special maternity ward at Södersjukhuset, n=45.

The expected to include is 100. Expected viable pregnancies: 50.

The maternal vaginal, fecal and oral microbiome will be sampled by "self-sampling" at home before, during and after the pregnancy, by this schedule:

1. Inclusion, before pregnancy after an appointment with the diabetic doctor or nurse. Or at the first visit at the special maternity care ward during pregnancy (around gestational week 8).

2. When the pregnancy is first discovered if the inclusion were before pregnancy.

3. Week 28.

4. When attending delivery ward in labor

5. 6-10 weeks postpartum from both the mother and the new-born. The tests will be sent to the obstetric research center at Södersjukhuset, where the tests will be saved in freezes. The analysis will be performed at CTMR at the Karolinska Institute.

Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant Women with type 1 diabetes

• Included as a patient at women's clinic Soderhospital in Stockholm

• Acceptant to sample her microbiome during pregnancy

Exclusion Criteria:

• Women without type 1 diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• sampling of microbiome
women will sample from vagina, feces, and saliva during pregnancy

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Danderyd	Sverige
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal complications during pregnancy	The frequency of Preeklampsia, hypertension and other pregnancy complications	through study completion, an average of 1 year
Secondary	Fetal complications during pregnancy	Large for gestational age	through study completion, an average of 1 year