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

NCT ID: NCT02199470

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

TYPE 1 DIABETES

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

C-peptide minimal detectable

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

No interventions assigned to this group

C-peptide sustained

C-peptide level between higher or equal to 0,08 ng/mL

No interventions assigned to this group

C-peptide not detectable

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gonca Incemehmet Tamer

OTHER

Sponsor Role: lead

Responsible Party

Gonca Incemehmet Tamer

Istanbul Medeniyet University, Goztepe Research and Training Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gonca Incemehmet Tamer, I

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Locations

Medeniyet University Goztepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

http://creativecommons.org/licenses/by-nc-nd/3.0/

Joslin Medalist Study

Other Identifiers

MUGEAH-1

Identifier Type: -

Identifier Source: org_study_id