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

TYPE 1 DIABETES Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199470
• Other study ID #: MUGEAH-1
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: September 2, 2016
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• TYPE 1 DIABETES

Locations

Country	Name	City	State
Turkey	Medeniyet University Goztepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gonca Incemehmet Tamer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We aimed to evaluate the extent of ß-cell function by determining fasting levels of C-peptide and those after meal stimulus.		1 day (the duration of mixed test is 90 minutes)	No

External Links

•   Joslin Medalist Study