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Diabetes Cohort in French Amazonia (CoDiAm)
| Condition or disease |
|---|
| Diabetes Mellitus Adults |
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 [Patient Registry] |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Diabetes Cohort in French Amazonia |
| Actual Study Start Date : | April 8, 2019 |
| Estimated Primary Completion Date : | April 8, 2021 |
| Estimated Study Completion Date : | May 8, 2021 |
- Improvement of patient care [ Time Frame: 2 years ]Number of health complications in diabetes mellitus ...
Biospecimen Retention: Samples Without DNA
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Nadia SABBAH, MD | +594594394150 | nadia.sabbah@ch-cayenne.fr | |
| Contact: DRCI CAYENNE | +594594395385 | cicec@ch-cayenne.fr |
| France | |
| Centre Hospitalier de Cayenne | Recruiting |
| Cayenne, French Guiana, France, 97306 | |
| Contact: Mathieu Nacher, MD, PhD +594594395024 ext 5024 mathieu.nacher@ch-cayenne.fr | |
| Contact: DRCI CAYENNE +5945945385 cicec@ch-cayenne.fr | |
| Principal Investigator: Nadia SABBAH, MD | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 10, 2019 | ||||||||
| First Posted Date | July 15, 2019 | ||||||||
| Last Update Posted Date | July 15, 2019 | ||||||||
| Actual Study Start Date | April 8, 2019 | ||||||||
| Estimated Primary Completion Date | April 8, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Improvement of patient care [ Time Frame: 2 years ] Number of health complications in diabetes mellitus ...
|
||||||||
| 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 | Diabetes Cohort in French Amazonia | ||||||||
| Official Title | Diabetes Cohort in French Amazonia | ||||||||
| Brief Summary | CoDiAm aims to collect clinical, biological and social data of diabetic patients in French Guiana. | ||||||||
| 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 [Patient Registry] | ||||||||
| Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | 2 Years | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
blood samples
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Diabetic patients living in French Guiana | ||||||||
| Condition |
|
||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 8, 2021 | ||||||||
| Estimated Primary Completion Date | April 8, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04020068 | ||||||||
| Other Study ID Numbers | CODIAM | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier de Cayenne | ||||||||
| Study Sponsor | Centre Hospitalier de Cayenne | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Centre Hospitalier de Cayenne | ||||||||
| Verification Date | July 2019 | ||||||||
