Clinical Trials Directory

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UnknownNCT02220257

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
140 (estimated)
Sponsor
Poznan University of Medical Sciences · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2012-01-01
Primary completion
2014-08-01
Completion
2015-12-01
First posted
2014-08-19
Last updated
2014-08-19

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02220257. Inclusion in this directory is not an endorsement.