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

Sponsor
Gonca Incemehmet Tamer (Other)
Overall Status
Completed
CT.gov ID
NCT02199470
Collaborator
(none)
135
Enrollment
1
Location
23
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    135 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    β-cell Function in Type Diabetes May Not Be As Low As Presumed
    Study Start Date :
    Apr 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Mar 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    C-peptide minimal detectable

    C-peptide level between 0,01-0,08 ng/mL
    C-peptide sustained

    C-peptide level between higher or equal to 0,08 ng/mL
    C-peptide not detectable

    C- peptide level equal to or lower than 0,01 ng/mL

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medeniyet University Goztepe Training and Research Hospital Istanbul Turkey 34730

    Sponsors and Collaborators

    • Gonca Incemehmet Tamer

    Investigators

    • Principal Investigator: Gonca Incemehmet Tamer, I, Istanbul Medeniyet University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gonca Incemehmet Tamer, Istanbul Medeniyet University, Goztepe Research and Training Hospital, Istanbul Medeniyet University
    ClinicalTrials.gov Identifier:
    NCT02199470
    Other Study ID Numbers:
    • MUGEAH-1
    First Posted:
    Jul 24, 2014
    Last Update Posted:
    Sep 5, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Gonca Incemehmet Tamer, Istanbul Medeniyet University, Goztepe Research and Training Hospital, Istanbul Medeniyet University
    β-CELLS,
    MIXED MEAL TEST,
    C-PEPTİDE
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Sep 5, 2016