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

September 2, 2016 updated by: Gonca Incemehmet Tamer

β-cell Function in Type 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34730
        • Medeniyet University Goztepe Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with type 1 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gonca Incemehmet Tamer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUGEAH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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