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Women and Risk of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870724
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Norwegian Diabetes Association
Information provided by (Responsible Party):
Christin Waage, University of Oslo

Tracking Information
First Submitted Date February 27, 2019
First Posted Date March 12, 2019
Last Update Posted Date March 12, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2019)
Type 2 diabetes [ Time Frame: 2 years ]
Prevalence
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women and Risk of Type 2 Diabetes
Official Title Women and Risk of Type 2 Diabetes
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buccal swabs
Sampling Method Non-Probability Sample
Study Population Middle aged women, previous participants in the STORK G study still living in Norway
Condition Type 2 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 8, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Moved out of Norway
Sex/Gender
Sexes Eligible for Study: Female
Ages 27 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03870724
Other Study ID Numbers 2018/2517
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Christin Waage, University of Oslo
Study Sponsor University of Oslo
Collaborators Norwegian Diabetes Association
Investigators
Principal Investigator: Anne Karen Jenum University of Oslo
PRS Account University of Oslo
Verification Date March 2019