Clinical Trial on Diabetes Mellitus, Adults - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Detailed Description

Diabetes is a very common disease in French Guiana. This disease is caused by the body's inability to metabolise sugar properly. A diet and treatment with tablets are enough for some patients, while others may need insulin injections. In the long term, high blood sugar levels may cause problems to the small and large blood vessels in the body. This is complicated by nerve, renal and retinal damage, as well as increased risks of cardiac and vascular events (such as strokes or heart attacks.) It appears that diabetes is more common and more severe in French Guiana than in other parts of France. It seems that the types of diabetes found here are more variable than those found in France, and that patients tend to be diagnosed at a later stage. We would this like to better understand diabetes and its evolution in French Guiana.

This research is aimed at diabetic patients and it is being carried out in the Andrée Rosemon Hospital Centre, the Ouest Guyanais Hospital Centre as well as in other Primary Healthcare Centres. At some point in the future, some private health centres may also invite their patients to take part in this study.

Study Type

Observational

Enrollment (Anticipated)

3000

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

France
- French Guiana
  - Cayenne, French Guiana, France, 97306
    - Recruiting
    - Centre Hospitalier de Cayenne
    - Contact:
      
      Mathieu Nacher, MD, PhD
      
      Phone Number: 5024 +594594395024
      
      Email: mathieu.nacher@ch-cayenne.fr
    - Contact:
      
      DRCI CAYENNE
      
      Phone Number: +5945945385
      
      Email: cicec@ch-cayenne.fr
    - Principal Investigator:
      
      Nadia SABBAH, MD

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

Diabetic patients living in French Guiana

Description

Inclusion Criteria:

Patients with diabetes
At least 18 years old

Exclusion Criteria:

Less than 18 years old
Patients under legal guardianship
Patients' refusal to participate
Patients living outside French Guiana

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of patient care Time Frame: 2 years	Number of health complications in diabetes mellitus ...	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Cayenne

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)

April 8, 2019

Primary Completion (Anticipated)

April 8, 2021

Study Completion (Anticipated)

May 8, 2021

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)