SweMaMi DMI, Microbiome

SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: sampling of microbiome

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Eva Wiberg-Itzel, PhD; Phone Number: +46708775346; Email: eva.itzel@telia.com

Study Locations

• Sweden
  • Stockholm, Sweden, 18239
    • Recruiting
    • Eva Wiberg-Itzel
  • Sverige
    • Danderyd, Sverige, Sweden, 18239
      • Not yet recruiting
      • Eva Wiberg-Itzel
      • Contact: Eva Wiberg-Itzel; Phone Number: +46708775346; Email: eva.itzel@telia.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant women with type 1 diabetes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
microbiome sampling; pregnant women with type 1 diabetes	Other: sampling of microbiome; women will sample from vagina, feces, and saliva during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal complications during pregnancy	The frequency of Preeklampsia, hypertension and other pregnancy complications	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal complications during pregnancy	Large for gestational age	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Eva Wiberg-Itzel, PhD, Karolinska Institute Sodersjukhuset Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Microbioma; maternal and fetal pregnacy outcomes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not discussed this question yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No