Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04346524
Study type Observational
Source Karolinska Institutet
Contact Eva Wiberg-Itzel, PhD
Phone +46708775346
Email eva.itzel@telia.com
Status Recruiting
Phase
Start date April 1, 2020
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4
Completed NCT02855307 - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes Phase 2