Women and Risk of Type 2 Diabetes

• Sponsor: University of Oslo (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03870724
• Collaborator: Norwegian Diabetes Association (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 27.2
• Patients Per Site Per Month: 18.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Women and Risk of Type 2 Diabetes
• Actual Study Start Date: Aug 27, 2019
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Type 2 diabetes [2 years]

   Prevalence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 27 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Moved out of Norway

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oslo, Faculty of Medicine, Institute of Health and Society	Oslo		Norway	0316 Oslo

Sponsors and Collaborators

• University of Oslo
• Norwegian Diabetes Association

Investigators

• Principal Investigator: Anne Karen Jenum, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christin Waage, Postdoctor, University of Oslo
• ClinicalTrials.gov Identifier: NCT03870724
• Other Study ID Numbers: 2018/2517
• First Posted: Mar 12, 2019
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christin Waage, Postdoctor, University of Oslo: Prevention; Cardiovascular diseases; Physical activity; Ethnic differences in health; Risk factors
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 27, 2021