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The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome (POZREM)

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ClinicalTrials.gov Identifier: NCT02220257
Recruitment Status : Unknown
Verified August 2014 by Paweł Niedźwiecki, Poznan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Paweł Niedźwiecki, Poznan University of Medical Sciences

Brief 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. 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.


Condition or disease
Diabetes Mellitus Type 1 Remission of Type 1 Diabetes Chronic Complications of Diabetes

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 Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
Study Start Date : January 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Newly diagnosed type 1 diabetes



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
  2. Age 18-35 years
  3. Education with regard to intensive functional insulin therapy at the time of diagnosis
  4. Patient consent to participation in the study

Exclusion Criteria:

  1. Acute inflammation (serum C-reactive protein concentration (hsCRP) >10mg/L, leukocytosis >15x109/L, erythrocyte sedimentation rate (OB) >30 mm/h)
  2. Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
  3. History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
  4. Other autoimmunological diseases other than diabetes
  5. Not confirming type 1 diabetes after obtaining results of autoantibodies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220257


Locations
Poland
Franciszek Raszeja Hospital; Poznan University of Medical Science
Poznań, Greater Poland, Poland, 60-834
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Principal Investigator: Paweł Niedźwiecki, MD Poznan University of Medical Sciences

Responsible Party: Paweł Niedźwiecki, MD Paweł Niedźwiecki, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02220257     History of Changes
Other Study ID Numbers: REMISSIONDM1
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

Keywords provided by Paweł Niedźwiecki, Poznan University of Medical Sciences:
diabetes mellitus type 1
remission, honeymoon
microangiopathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases