Trials / Unknown
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.