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

Sponsors

Lead Sponsor: Gonca Incemehmet Tamer

Source Istanbul Medeniyet University
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.

Overall Status Completed
Start Date April 2013
Completion Date March 2015
Primary Completion Date July 2014
Study Type Observational
Primary Outcome
Measure 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)
Enrollment 135
Condition
Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gonca Incemehmet Tamer, I Principal Investigator Istanbul Medeniyet University
Location
Facility: Medeniyet University Goztepe Training and Research Hospital
Location Countries

Turkey

Verification Date

September 2016

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Istanbul Medeniyet University

Investigator Full Name: Gonca Incemehmet Tamer

Investigator Title: Istanbul Medeniyet University, Goztepe Research and Training Hospital

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: C-peptide minimal detectable

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

Label: C-peptide sustained

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

Label: C-peptide not detectable

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

Study Design Info

Observational Model: Case Control

Time Perspective: Prospective

Source: ClinicalTrials.gov