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

Diabetes Mellitus Type 1 Clinical Trial

— POZREM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02220257
• Other study ID #: REMISSIONDM1
• Status: Active, not recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: August 18, 2014
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Complications of Diabetes
• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1
• Remission of Type 1 Diabetes

Locations

Country	Name	City	State
Poland	Franciszek Raszeja Hospital; Poznan University of Medical Science	Poznan	Greater Poland

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No