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

August 18, 2014 updated by: Paweł Niedźwiecki, Poznan University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Greater Poland
      • Poznań, Greater Poland, Poland, 60-834
        • Franciszek Raszeja Hospital; Poznan University of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Newly diagnosed type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Paweł Niedźwiecki, MD, Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMISSIONDM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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