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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02220257
Acronym
POZREM
Enrollment
140
Registered
2014-08-19
Start date
2012-01-31
Completion date
2015-12-31
Last updated
2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

diabetes mellitus type 1, remission, honeymoon, microangiopathy

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.

Interventions

None listed

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026