Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-03 @ 7:39 PM
Study NCT ID:
NCT02220257
Status:
UNKNOWN
Last Update Posted:
2014-08-19
First Post:
2014-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome
Sponsor:
Poznan University of Medical Sciences
Organization:
Study Overview
Official Title:
Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POZREM
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: