Overview

This trial is active, not recruiting.

Conditions diabetes mellitus type 1, remission of type 1 diabetes, chronic complications of diabetes
Sponsor Poznan University of Medical Sciences
Start date January 2012
End date August 2014
Trial size 140 participants
Trial identifier NCT02220257, REMISSIONDM1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

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.

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
Principal investigator Paweł Niedźwiecki, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Poznan University of Medical Sciences.