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Type 2 Diabetes MellitusNCT03870724

Women and Risk of Type 2 Diabetes

An observational study of Type 2 Diabetes Mellitus, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a follow-up survey of women, 10-12 years after they were included in the population-based Stork Groruddalen study of pregnant women, primarily set up to study gestational diabetes and related health issues in pregnancy in a multiethnic population. Read more about this study

Who is it for?
Ages 27 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
How many people
383 participants
Where
1 siteNorway
Study dates
27 Aug 2019to 30 Mar 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 27 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Middle aged women, previous participants in the STORK G study still living in Norway

Who may be able to join

  • Previous participants in the STORK G study still living in Norway

Who cannot join

  • Moved out of Norway

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University of Oslo, Faculty of Medicine, Institute of Health and Society

    Oslo, 0316 Oslo

Other trials in Norway

About this study

This is a follow-up survey of women, 10-12 years after they were included in the population-based Stork Groruddalen study of pregnant women, primarily set up to study gestational diabetes and related health issues in pregnancy in a multiethnic population. The investigators will now update the information about the health status of these women to study the development of risk factors for type 2 diabetes and cardiovascular diseases.

Read the detailed description

The STORK-Groruddalen is a cohort study of 823 pregnant women. Participation rate was high due to facilitation for ethnic minorities and data collection at the local Health Centres, set up to study ethnic differences in health to inform prevention strategies to reduce these differences. The investigators have published many papers from this well charatertized cohort, about gestational diabetes and related health issues in pregnancy. Participants have agreed to be contacted for subsequent follow-up surveys.

The inivestigators are now planning a follow-up study of these woman during 2019-2022, to study trajectories for risk factors for type 2 diabetes and cardiovascular diseases such as BMI, blood pressure, lipids, behavioural factors, physical activity and mental health and other health issues. The investigators will collect selfreported information through questionnaires, perform clinical measurements and take blood samples and buccal swabs. Collecting updated information about a range of health outcomes for women in this cohort will, together with already collected data, enable us to study the development of risk factors for type 2 diabetes and cardiovascular diseases in a life course perspective.

Keywords
Prevention, Cardiovascular diseases, Physical activity, Ethnic differences in health, Risk factors
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type 2 diabetes

    Prevalence

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start27 Aug 2019
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

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
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03870724
Sponsor's protocol ID
2018/2517
Status last verified
Nov 2022
First submitted
27 Feb 2019
Last updated
3 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shakeel N, Jenum AK, Waage CW, Mdala I, Werner EL, Natvig B, Braend AM. Symptom burden in middle-aged women, the role of immigrant status. BMC Public Health. 2025 Nov 3;25(1):3759. doi: 10.1186/s12889-025-25093-x.

    PubMed 41184925

  • Waage CW, Jenum AK, Mdala I, Lee-Odegard S, Braend AM, Sletner L, Berg JP, Birkeland KI. Diabetes and prediabetes among women universally screened for gestational diabetes: a multi-ethnic, population-based, prospective study with eleven years follow-up. BMC Public Health. 2025 Apr 3;25(1):1264. doi: 10.1186/s12889-025-22493-x.

    PubMed 40181282

  • Waage CW, Toftemo I, Braend AM, Sletner L, Sommer C, Birkeland KI, Richardsen KR, Shakeel N, Vollestad NK, Jenum AK. Cohort profile update: the Norwegian STORK Groruddalen (STORK G) pregnancy and birth cohort-the role of ethnicity and causal pathways for obesity, type 2 diabetes, cardiovascular disease and other health issues. BMJ Open. 2023 Oct 29;13(10):e076251. doi: 10.1136/bmjopen-2023-076251.

    PubMed 37899145

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by University of Oslo at 1 site in Norway.

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 1 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: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type 2 diabetes (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03870724, which also lists 3 linked publications.

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 3 Nov 2022.

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