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OpenTrials
Completed

NCT Number: NCT02199470

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medeniyet University Goztepe Training and Research Hospital

Istanbul, 34730, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

    Time frame: 1 day (the duration of mixed test is 90 minutes)

Sponsors and collaborators

Lead sponsor

Gonca Incemehmet Tamer

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 24, 2014
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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