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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria. Age 18-35 years Education with regard to intensive functional insulin therapy at the time of diagnosis Patient consent to participation in the study Exclusion Criteria: Acute inflammation (serum C-reactive protein concentration (hsCRP) >10mg/L, leukocytosis >15x109/L, erythrocyte sedimentation rate (OB) >30 mm/h) Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis) Other autoimmunological diseases other than diabetes Not confirming type 1 diabetes after obtaining results of autoantibodies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed type 1 diabetes<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus type 1, remission, honeymoon, microangiopathy