Type 1 Diabetes Clinical Trial
Official title:
Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus
The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.
The study will include approximately 200 patients, male and female, with DM1 who are being
followed in the outpatient diabetic clinic of our hospital.
Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The
visit will take place in the morning in a fasting state of about 12 hours. Demographic data
will be recorded along with the patients' habits, lifestyle, current medication and complete
medical history of concomitant diseases.
This will be followed by anthropometric measurements (weight, height, BMI) and afterwards
blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and
lipids. Part of each blood sample will be collected in tubes containing EDTA to determine
fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a
morning urine sample by calculating urinary albumin to creatinine ratio (ACR).
The functionality of the heart's autonomic nervous system will be assessed through the use of
heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep
inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing
from the supine to the standing position will also be recorded. Subsequently, the
distensibility of the large vessels will be determined, by calculating the conduction
velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity
(PWV)).
Finally, a full transthoracic echocardiographic study will be carried out to assess
functionality, systolic and diastolic, of the left ventricle (LV).
All data will be recorded in an electronic database for statistical processing.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
| Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
| Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
| Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
| Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
| Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
| Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
| Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
| Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
| Recruiting |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
| Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
| Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
| Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
| Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |