- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04847414
Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt
Aim of our work:
First aim: Classify patients with adult-onset diabetes according to the novel classification into new subgroups, depending on multiple variables related clinically to those patients.
Second aim: To identify the association between the new classification subgroups and the presence of common microvascular complications (retinopathy, nephropathy, and neuropathy), which can help in the early prediction of these complications and their early management.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
We will conduct an observational cross-sectional study and cluster analysis for patients from different Diabetes clinics and tertiary centres located in different governorates in Upper Egypt. Our participants in this study will be divided into two groups:
- The first group will be as a prospective group, All necessary examinations and investigations will be performed for every patient of this group during their clinic visit at the time of registration to this study.
- The second group will be the retrospective group. Data for those patients will be collected from electronic records and/or paper records in collaboration with different diabetes centres and clinics scattered in Upper Egypt governorates. We will collect clinical and lab data as much as we can. All available data for this group at end of this study will be used in the clustering of this group.
Then we will use the above data from both groups to classify diabetic patients to the new clusters and to find the association between those clusters and the incidence of microvascular complications.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Sohag, Egypten
- Sohag University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Adult-onset DM type 2 diagnosed patients according to current ADA recommendations, aged <18 years old and within 3 years from the time of diagnosis.
Exclusion Criteria:
1- Patients diagnosed with Gestational DM or rare types of diabetes like monogenic diabetes types, such as maturity-onset diabetes of the young (MODY), diabetes secondary to steroid use, cystic fibrosis, hemochromatosis, and pancreatic diabetes according to ADA criteria.
2- Patients diagnosed with non-diabetic kidney diseases, such as chronic glomerulonephritis, vasculitis, polycystic kidney disease, and renal cancer or patients with a transplanted kidney were excluded from the analysis for diabetic kidney disease.
3- Patients diagnosed with retinopathy due to non-diabetic causes or diagnosed with neuropathy due to non-diabetic causes will be excluded from the analysis for diabetic retinopathy and neuropathy, respectively.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
prospective group
all needed data will be collected from patients in this group through performing full medical examination and doing all necessary investigations for them
|
we will do some necessary investigations for prospective group
|
|
retrospective group
all needed data will be collected from medical records either electronic or paper based from different diabetes clinics in upper Egypt
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in HbA1C
Tidsram: 3 months
|
percent %
|
3 months
|
|
change in BMI
Tidsram: 3 months
|
kg/m2
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HOMA-IR
Tidsram: 6 months
|
calculated by HOMA calculator presented by Oxford University
|
6 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Soh-Med-21-04-16
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .