Diabetes MellitusDiab1FitNCT04968171
Diabetes Type 1 and Fitness.
An observational study of Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Age 18-35 years,
- New onset type 1 diabetes (confirmed by the presence of antibodies - antyGAD, ICA, IA2)
- Treatment with intensive insulin therapy,
- Written consent to participate in the study.
Who cannot join
- Contraindications to the exercise test (including: recent myocardial infarction, unstable coronary artery disease, hypertrophic cardiomyopathy, serious arrhythmias, myocarditis, advanced systemic diseases, hyperthyroidism, recurrent anemia),
- Mental disorders,
- Co-morbidities with potential impact on physical performance (e.g. cancer, renal failure, liver failure, rheumatic diseases, COPD, asthma, anemia, hypothyroidism and hyperthyroidism),
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
Poznan, 60-834
Justyna Flotyńska, 728328961 ext. +48, justynaflotynska@gmail.com
Aleksandra Uruska, PhD, 607620750 ext. +48, aleksandrauruska@gmail.com
About this study
Official title: Assessment of Physical Effort in People With Newly Diagnosed Type 1 Diabetes Mellitus and Its Impact on: Partial Clinical Remission, Insulin Resistance, HDL Cholesterol Function, Immune Function and Length of Life.
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.
Read the detailed description
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
- Lipid profile
- Glycated hemoglobin level (HbA1c)
- 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.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus type 1, Physical activity, Clinical remission
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max [ml/min/kg]
VO2 max level evaluated during ergospirometry (COSMED K5)
Measured: 1 year
Partial clinical remission time
Presence [(4 x insulin dose (j/kg/d)] ≤ 9] and duration [time] of partial clinical remission
Measured: 1 year
Secondary outcomes (12)
Triglicerydes concentriation in serum [mg/dl]
Changes in serum triglyceride levels
Measured: Change from baseline in apolipoproteins' at 6 and 12 months
LDL-C concentriation in serum [mg/dl]
Changes in serum LDL levels
Measured: Change from baseline in apolipoproteins' at 6 and 12 months
HDL-C concentriation in serum [mg/dl]
Changes in serum HDL levels
Measured: Change from baseline in apolipoproteins' at 6 and 12 months
Total Cholesterol concentriation in serum [mg/dl]
Changes in serum Total-CH levels
Measured: Change from baseline in apolipoproteins' at 6 and 12 months
Lipid tissue content [%]
Evaluation of lipid tissue content prior to yearly visit.
Measured: 5 years
A1c [%]
Changes in serum A1c levels
Measured: 5 years
Daily insulin requirement [u/kg/d]
Sum of insulin units administered in the day prior to yearly visit.
Measured: 1 year
Retinopathy
Evaluation of retinopathy (ophthalmology assessment)
Measured: 5 years
Neuropathy
Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard)
Measured: 5 years
eGFR [ml/min/1,73m2]
Assessment of glomerular filtration and renal filtration function
Measured: 5 years
Creatynine [mg/dl]
Assessment of renal function
Measured: 5 years
Albumine to creatynine ratio ACR [mg/g]
Assessment of renal function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968171
- Sponsor's protocol ID
- 1050/19
- Acronym
- Diab1Fit
- Status last verified
- Jul 2021
- First submitted
- 13 Aug 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Effort in People With Newly Diagnosed Type 1 Diabetes Mellitus and Its Impact on: Partial Clinical Remission, Insulin Resistance, HDL Cholesterol Function, Immune Function and Length of Life.
- ClinicalTrials.gov ID
- NCT04968171
- Acronym / sponsor ID
- Diab1Fit / 1050/19
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus type 1, Physical activity, Clinical remission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Lipid profile
- Glycated hemoglobin level (HbA1c)
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age 18-35 years,
- New onset type 1 diabetes (confirmed by the presence of antibodies - antyGAD, ICA, IA2)
- Treatment with intensive insulin therapy,
- Written consent to participate in the study.
Key exclusion criteria (4 listed)
- Contraindications to the exercise test (including: recent myocardial infarction, unstable coronary artery disease, hypertrophic cardiomyopathy, serious arrhythmias, myocarditis, advanced systemic diseases, hyperthyroidism, recurrent anemia),
- Mental disorders,
- Co-morbidities with potential impact on physical performance (e.g. cancer, renal failure, liver failure, rheumatic diseases, COPD, asthma, anemia, hypothyroidism and hyperthyroidism),
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VO2max [ml/min/kg]
Time frame: 1 year
VO2 max level evaluated during ergospirometry (COSMED K5)
Partial clinical remission time
Time frame: 1 year
Presence [(4 x insulin dose (j/kg/d)] ≤ 9] and duration [time] of partial clinical remission
12 secondary outcomes
Triglicerydes concentriation in serum [mg/dl]
Time frame: Change from baseline in apolipoproteins' at 6 and 12 months
LDL-C concentriation in serum [mg/dl]
Time frame: Change from baseline in apolipoproteins' at 6 and 12 months
HDL-C concentriation in serum [mg/dl]
Time frame: Change from baseline in apolipoproteins' at 6 and 12 months
Total Cholesterol concentriation in serum [mg/dl]
Time frame: Change from baseline in apolipoproteins' at 6 and 12 months
Lipid tissue content [%]
Time frame: 5 years
A1c [%]
Time frame: 5 years
Daily insulin requirement [u/kg/d]
Time frame: 1 year
Retinopathy
Time frame: 5 years
Neuropathy
Time frame: 5 years
eGFR [ml/min/1,73m2]
Time frame: 5 years
Creatynine [mg/dl]
Time frame: 5 years
Albumine to creatynine ratio ACR [mg/g]
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max [ml/min/kg] (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.