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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02199470
Enrollment
135
Registered
2014-07-24
Start date
2013-04-30
Completion date
2015-03-31
Last updated
2016-09-05

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

Conditions

TYPE 1 DIABETES

Keywords

β-CELLS,, MIXED MEAL TEST,, C-PEPTİDE

Brief summary

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

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.

Interventions

None listed

Sponsors

Gonca Incemehmet Tamer
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

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