Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 21, 2020
Sponsor:
Collaborator:
Norwegian Diabetes Association
Information provided by (Responsible Party):
Christin Waage, University of Oslo

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women and Risk of Type 2 Diabetes
Actual Study Start Date : August 27, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Type 2 diabetes [ Time Frame: 2 years ]
    Prevalence


Biospecimen Retention:   Samples With DNA
Buccal swabs

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   27 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Middle aged women, previous participants in the STORK G study still living in Norway
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Moved out of Norway
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870724


Locations
Layout table for location information
Norway
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
Layout table for investigator information
Principal Investigator: Anne Karen Jenum University of Oslo
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Christin Waage, Postdoctor, University of Oslo
ClinicalTrials.gov Identifier: NCT03870724    
Other Study ID Numbers: 2018/2517
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christin Waage, University of Oslo:
Prevention
Cardiovascular diseases
Physical activity
Ethnic differences in health
Risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases