Clinical trial NCT02220257: The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome
Official title: Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 1
Remission of Type 1 Diabetes
Chronic Complications of Diabetes
Keywords: diabetes mellitus type 1
remission, honeymoon
microangiopathy
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 240 consecutive patients, including 77 women and 143 men hospitalized at the Department of Internal Medicine and Diabetology of Poznan University of Medical Sciences between 2004 and 2007 due to newly diagnosed type 1 diabetes.

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.

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

Primary outcomes:
measure: Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
timeFrame: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Franciszek Raszeja Hospital; Poznan University of Medical Science
state: Greater Poland
Study officials:
affiliation: Poznan University of Medical Sciences
name: Paweł Niedźwiecki, MD
role: PRINCIPAL_INVESTIGATOR
References: