- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01961466
Diabetes and Psychological Profile (DPP)
September 3, 2019 updated by: Centre Hospitalier Universitaire Dijon
Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.
This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin.
The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
592
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dijon, France, 21079
- CHU Dijon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Type 1 or 2 Diabetes
Description
Inclusion Criteria:
- patients who have been given information about the research
- patients with National Health Insurance
- diabetic patients (type 1 or 2)
- patients > 18 ans
Exclusion Criteria:
- Adult patients under guardianship or intellectually dependent
- patients without National Health Insurance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diabetic patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire
Time Frame: At 1 year
|
At 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on the scales
Time Frame: At 1 year
|
At 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
October 10, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Actual)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 3, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAUVET-GELINIER 2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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