β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed

Study Overview
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Brief Summary
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Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

Detailed Description
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Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus. Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study. Ethics comittee of our hospital approved the study protocol, which was in accordance with the Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th minute post mixed meal) C-peptide levels of 54 will be measured by using an electrochemiluminescence assay. Two categorizations will be done using fasting (the first categorization ) and at 90th minute post mixed meal test (the second categorization) of C-peptide levels. For the first categorization; the groups will be classified as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at the 90th minute after the meal ≥150% of fasting C-peptide level.

Official Title
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β-cell Function in Type Diabetes May Not Be As Low As Presumed

Conditions
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TYPE 1 DIABETES

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetic patients who have accepted to have mixed meal tolarance test Exclusion Criteria: Patients with type 2 diabetes, patients with MODY

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| C-peptide minimal detectable<br>C-peptide level between 0,01-0,08 ng/mL | |
| C-peptide sustained<br>C-peptide level between higher or equal to 0,08 ng/mL | |
| C-peptide not detectable<br>C- peptide level equal to or lower than 0,01 ng/mL | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus. |  | 1 day (the duration of mixed test is 90 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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β-CELLS,, MIXED MEAL TEST,, C-PEPTİDE