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

NCT ID: NCT02220257

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Newly diagnosed type 1 diabetes

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Paweł Niedźwiecki

MD Paweł Niedźwiecki

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Niedźwiecki, MD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Sciences

Locations

Franciszek Raszeja Hospital; Poznan University of Medical Science

Poznan, Greater Poland Voivodeship, Poland

Countries

Poland

Other Identifiers

REMISSIONDM1

Identifier Type: -

Identifier Source: org_study_id