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

Poznan University of Medical Sciences (PUMS)

Status: Unknown

Conditions: Chronic Complications of Diabetes; Remission of Type 1 Diabetes; Diabetes Mellitus Type 1

Study type: Observational

Funder types: Other

Identifiers

NCT02220257

REMISSIONDM1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

Newly diagnosed type 1 diabetes