Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome

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

Sponsors

Lead sponsor: Poznan University of Medical Sciences

Source 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.

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.

Overall Status Unknown status
Start Date January 2012
Completion Date December 2015
Primary Completion Date August 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy) Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
Enrollment 140
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 35 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paweł Niedźwiecki, MD Principal Investigator Poznan University of Medical Sciences
Location
facility Franciszek Raszeja Hospital; Poznan University of Medical Science
Location Countries

Poland

Verification Date

August 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Poznan University of Medical Sciences

Investigator full name: Paweł Niedźwiecki

Investigator title: MD Paweł Niedźwiecki

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Newly diagnosed type 1 diabetes

Acronym POZREM
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov