Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Diab1Fit Study project aims to a multidirectional assessment of physical activity and its impact in people with type 1 diabetes (DM1). To the study are recruited people with newly diagnosed DM1, treated with intensive functional insulin therapy from the beginning of the disease. The study is planned to cover a minimum of 100 people with newly diagnosed DM1 and lead prospective observation of this group (for a minimum of 5-10 years). The investigators will evaluate the effect of VO2max in people with newly diagnosed DM1 on partial clinical remission. What is more the investigators also assess quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, mechanism linking VO2max with management of DM1 (longevity proteins, miostatin, insulin resistance) and immune function.
The Diab1Fit Study project aims to a multidirectional assessment of physical activity and its impact in people with type 1 diabetes (DM1). To the study are recruited people with newly diagnosed DM1, treated with intensive functional insulin therapy from the beginning of the disease. The study is planned to cover a minimum of 100 people with newly diagnosed DM1 and lead prospective observation of this group (for a minimum of 5-10 years). The investigators will evaluate the effect of VO2max in people with newly diagnosed DM1 on partial clinical remission. What is more the investigators also assess quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, mechanism linking VO2max with management of DM1 (longevity proteins, miostatin, insulin resistance) and immune function.
Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic. An additional visit to assess VO2max will be scheduled between 3 and 12 months of diabetes. The investigators will use an ergospirometer (COSMED K5 System) during an exercise test carried out on a cycloergometer (progressive exercise test). Moreover, the investigators will monitor glucose levels during the exercise test - using a continuous glucose monitoring system using the FreeStyle Libre Flash Glucose Monitoring System (Abbott). A week before the exercise test, the investigators will borrow a Garmin watch that assesses the patient's daily activities
During each follow-up will be assessed parameters:
The presence of partial clinical remission, according to Mortensen: HbA1c (%) + [4 x dawka insuliny (j/kg/d)] †9.
Data on lifestyle (diet, exercise), family history and smoking.
Anthropometric data:
BMI (body mass index) = weight [kg]/(height [m])2
Waist circumference
WHR - waist to hip ratio
daily insulin requirement (U/kg m.c./d),
eGDR (estimated glucose disposal rate) = 24.31-12.22(WHR)-3.29(hypertension 0/1)-0.57( HbA1c [mg/kg/min])
VAI (visceral adiposity index):
For women = [Waist circumference/36.58+(1.89xBMI)]x(TG/0.81)x(1.52/HDL), For men = [Waist circumference /39.68+(1.88xBMI)]x(TG/1.03)x(1.31/HDL),
body composition analysis
Parameters of diabetes metabolic control
Protein glycation end products Expected impact of the research project on the development of science, civilization and society: The study confirms the great importance of aerobic physical activity in the treatment of people with DM1 from the beginning of the diagnosis. The project aims to pay attention to the importance of physical activity among people with DM1 and to popularize this method of treatment. The obtained results will be used for the prospective observation of this group to assess the impact of physical effort on the development of chronic complications and will allow planning intervention studies in this population. The results of this study will help enrich knowledge about the body's ability to exercise among people with DM1 and show new intervention solutions. It may contribute to changing the recommendations of scientific societies. What is more knowledge about prolonging partial clinical remission and thereby reducing the risk of developing chronic complications will contribute to the introduction of new recommendations. Research on exercise in diabetes and longevity proteins will increase the length and quality of life of people with DM1.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with newly diagnosed diabetes mellitus type 1 | People with newly diagnosed diabetes mellitus type 1 admitted to the Department of Internal Medicine and Diabetology. Treated with intensive insulin therapy. Measurement of VO2max between 3 and 12 month after diagnosis. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| VO2max [ml/min/kg] | VO2 max level evaluated during ergospirometry (COSMED K5) | 1 year |
| Partial clinical remission time | Presence [(4 x insulin dose (j/kg/d)] †9] and duration [time] of partial clinical remission | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Triglicerydes concentriation in serum [mg/dl] | Changes in serum triglyceride levels | Change from baseline in apolipoproteins' at 6 and 12 months |
| LDL-C concentriation in serum [mg/dl] | Changes in serum LDL levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
A minimum of 100 people with newly diagnosed type 1 diabetes hospitalized in the Department of Internal Medicine and Diabetology Poznan University of Medical Sciences.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences | Recruiting | Poznan | 60-834 | Poland |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from baseline in apolipoproteins' at 6 and 12 months |
| HDL-C concentriation in serum [mg/dl] | Changes in serum HDL levels | Change from baseline in apolipoproteins' at 6 and 12 months |
| Total Cholesterol concentriation in serum [mg/dl] | Changes in serum Total-CH levels | Change from baseline in apolipoproteins' at 6 and 12 months |
| Lipid tissue content [%] | Evaluation of lipid tissue content prior to yearly visit. | 5 years |
| A1c [%] | Changes in serum A1c levels | 5 years |
| Daily insulin requirement [u/kg/d] | Sum of insulin units administered in the day prior to yearly visit. | 1 year |
| Retinopathy | Evaluation of retinopathy (ophthalmology assessment) | 5 years |
| Neuropathy | Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard) | 5 years |
| eGFR [ml/min/1,73m2] | Assessment of glomerular filtration and renal filtration function | 5 years |
| Creatynine [mg/dl] | Assessment of renal function | 5 years |
| Albumine to creatynine ratio ACR [mg/g] | Assessment of renal function | 5 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |