Type 1 DiabetesNCT04346524
SweMaMi DMI, Microbiome
An observational study of Type 1 Diabetes, run by Karolinska Institutet at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- sampling of microbiome
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Apr 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women with type 1 diabetes
Who may be able to join
- Pregnant Women with type 1 diabetes
- Included as a patient at women's clinic Soderhospital in Stockholm
- Acceptant to sample her microbiome during pregnancy
Who cannot join
- Women without type 1 diabetes
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Eva Wiberg-Itzel
Danderyd, Sverige, 18239
Eva Wiberg-Itzel, +46708775346, eva.itzel@telia.com
- Recruiting
Eva Wiberg-Itzel
Stockholm, 18239
Eva Wiberg-Itzel, Professor, +4686163768, eva@itzel.eu
Per Tornvall, Professor, +4686161000, per@tornvall.ki
About this study
Official title: 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.
Read the 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:
- 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).
- When the pregnancy is first discovered if the inclusion were before pregnancy.
- Week 28.
- When attending delivery ward in labor
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- sampling of microbiome
- Keywords
- Type 1 diabetes, Microbioma, maternal and fetal pregnacy outcomes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling of microbiomeOther
women will sample from vagina, feces, and saliva during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| microbiome sampling | pregnant women with type 1 diabetes Receives: Other: sampling of microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal complications during pregnancy
The frequency of Preeklampsia, hypertension and other pregnancy complications
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Fetal complications during pregnancy
Large for gestational age
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Eva Wiberg-Itzel, PhD, Principal investigator, Karolinska Institute Sodersjukhuset Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346524
- Sponsor's protocol ID
- DM1
- Status last verified
- Nov 2021
- First submitted
- 9 Apr 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not discussed this question yet
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy
- ClinicalTrials.gov ID
- NCT04346524
- Acronym / sponsor ID
- DM1
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Microbioma, maternal and fetal pregnacy outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- When the pregnancy is first discovered if the inclusion were before pregnancy.
- Week 28.
- When attending delivery ward in labor
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microbiome sampling | – | Other: sampling of microbiomepregnant women with type 1 diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women with type 1 diabetes
Key inclusion criteria (3 listed)
- Pregnant Women with type 1 diabetes
- Included as a patient at women's clinic Soderhospital in Stockholm
- Acceptant to sample her microbiome during pregnancy
Key exclusion criteria (1 listed)
- Women without type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling of microbiomewomen will sample from vagina, feces, and saliva during pregnancy | Other | microbiome sampling |
Primary outcome
Maternal complications during pregnancy
Time frame: through study completion, an average of 1 year
The frequency of Preeklampsia, hypertension and other pregnancy complications
1 secondary outcome
Fetal complications during pregnancy
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Undecided. We have not discussed this question yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Wiberg-Itzel, PhD principal investigator
Karolinska Institute Sodersjukhuset Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Wiberg-Itzel, PhD (+46708775346, eva.itzel@telia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal complications during pregnancy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.