Diabetes Mellitus Type 1POZREMNCT02220257
The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome
An observational study of Diabetes Mellitus Type 1 and Remission of Type 1 Diabetes, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diabetes Mellitus Type 1, Remission of Type 1 Diabetes, Chronic Complications of Diabetes
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2012to Dec 2015
- 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: The study included 240 consecutive patients, including 77 women and 143 men hospitalized at the Department of Internal Medicine and Diabetology of Poznan University of Medical Sciences between 2004 and 2007 due to newly diagnosed type 1 diabetes.
Who may be able to join
- Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
- Age 18-35 years
- Education with regard to intensive functional insulin therapy at the time of diagnosis
- Patient consent to participation in the study
Who cannot join
- Acute inflammation (serum C-reactive protein concentration (hsCRP) >10mg/L, leukocytosis >15x109/L, erythrocyte sedimentation rate (OB) >30 mm/h)
- Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
- History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
- Other autoimmunological diseases other than diabetes
- Not confirming type 1 diabetes after obtaining results of autoantibodies
Trial locations and contacts
1 site in 1 country.
Poland1 site
Franciszek Raszeja Hospital; Poznan University of Medical Science
Poznan, Greater Poland Voivodeship, 60-834
About this study
Official title: Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses the influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
Read the detailed description
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
Clinical remission was defined as time in which all of the following criteria were met: HbA1c below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide concentration above 0.5 ng / ml. Patients were divided into those who were in remission at any time during follow-up (remitters) and non-remitters.
At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy, diabetic kidney disease and neuropathy) was evaluated.
- Keywords
- diabetes mellitus type 1, remission, honeymoon, microangiopathy
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| Newly diagnosed type 1 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
Measured: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionAug 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Niedźwiecki, Poznan University of Medical Sciences
- Investigators
- Paweł Niedźwiecki, MD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220257
- Sponsor's protocol ID
- REMISSIONDM1
- Acronym
- POZREM
- Status last verified
- Aug 2014
- First submitted
- 15 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
- ClinicalTrials.gov ID
- NCT02220257
- Acronym / sponsor ID
- POZREM / REMISSIONDM1
- Keywords
- diabetes mellitus type 1, remission, honeymoon, microangiopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- 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.
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses the influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
Detailed description
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
Clinical remission was defined as time in which all of the following criteria were met: HbA1c below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide concentration above 0.5 ng / ml. Patients were divided into those who were in remission at any time during follow-up (remitters) and non-remitters.
At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy, diabetic kidney disease and neuropathy) was evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed type 1 diabetes | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included 240 consecutive patients, including 77 women and 143 men hospitalized at the Department of Internal Medicine and Diabetology of Poznan University of Medical Sciences between 2004 and 2007 due to newly diagnosed type 1 diabetes.
Key inclusion criteria (4 listed)
- Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
- Age 18-35 years
- Education with regard to intensive functional insulin therapy at the time of diagnosis
- Patient consent to participation in the study
Key exclusion criteria (5 listed)
- Acute inflammation (serum C-reactive protein concentration (hsCRP) >10mg/L, leukocytosis >15x109/L, erythrocyte sedimentation rate (OB) >30 mm/h)
- Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
- History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
- Other autoimmunological diseases other than diabetes
- Not confirming type 1 diabetes after obtaining results of autoantibodies
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
Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
Time frame: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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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.
Paweł Niedźwiecki, MD principal investigator
Poznan University of Medical Sciences
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 Type 1 and Remission of Type 1 Diabetes, 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 5 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 19 Aug 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy) (time frame: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.). 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 19 Aug 2014.