C-peptide Concentrations in Type 2 Diabetes Treated With Insulin; is it Time to Revise the Treatment of Type 2 Diabetes

NCT ID: NCT04005261

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-03-01

Brief Summary

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C-peptide is used to evaluate beta cell reserves. Patients with type 2 diabetes are treated with insulin for different indications. Other than beta-cell insufficiency and organ failures, insulin treatment is needed for a specified period. The investigators want to evaluate beta cell reserves in patients with type 2 diabetes treated with insulin for at least six months to see if that is the case. The investigators also want to compare the characteristics of these patients according to their beta cell reserves.

Detailed Description

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In patients with type 2 diabetes, initiation of insulin therapy is indicated in several conditions such as severe insulin resistance, acute metabolic decompensations, surgery, pregnancy, and progression of diabetic complications, and also when glycemic control cannot be achieved with effective lifestyle regulation and non-insulin antidiabetic medications. Some of these indications are transient, and patients should be reassessed to choose the appropriate treatment options. Clinical inertia is one of the new topics expressed in the recent diabetes guidelines. The investigators aimed to investigate the beta cell reserves of the patients with type 2 diabetes who are treated with insulin, to see if they have insufficient insulin secretion and if not, to compare their characteristics.

Conditions

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Type 2 Diabetes Treated With Insulin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with type 2 diabetes treated with insulin

Patients with type 2 diabetes who have been using insulin for at least six months.

They should be older than 18 years The patients should be presented to the Diabetes Outpatient Clinics of Istanbul Medeniyet University Goztepe Training and Research Hospital

C-peptide concentrations

Intervention Type DIAGNOSTIC_TEST

The patients will be grouped by their C-peptide concentrations

Interventions

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C-peptide concentrations

The patients will be grouped by their C-peptide concentrations

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes who had been treated with insulin as a monotherapy or as a component of combination therapy for at least 6 months.

Exclusion Criteria

* Diagnosis of other types of diabetes,
* end-stage renal failure,
* history of renal transplantation,
* diabetic acute metabolic decompensation,
* decompensated heart failure,
* advanced liver disease,
* pregnancy,
* acute or chronic pancreatitis,
* pancreatic carcinoma,
* acute infections,
* use of medications that might affect glucose regulation (e.g. corticosteroids)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goztepe Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ayse N Erbakan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe N Erbakan, MD

Role: PRINCIPAL_INVESTIGATOR

IMU Doctoral program

Mehmet Uzunlulu, Prof

Role: STUDY_DIRECTOR

IMU Goztepe Education and Research Hospital

Locations

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IMU Goztepe Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Leighton E, Sainsbury CA, Jones GC. A Practical Review of C-Peptide Testing in Diabetes. Diabetes Ther. 2017 Jun;8(3):475-487. doi: 10.1007/s13300-017-0265-4. Epub 2017 May 8.

Reference Type BACKGROUND
PMID: 28484968 (View on PubMed)

Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW. C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001. Diabetes. 2004 Jan;53(1):250-64. doi: 10.2337/diabetes.53.1.250.

Reference Type BACKGROUND
PMID: 14693724 (View on PubMed)

American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.

Reference Type BACKGROUND
PMID: 30559235 (View on PubMed)

Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract. 2019 Jan;25(1):69-100. doi: 10.4158/CS-2018-0535. No abstract available.

Reference Type BACKGROUND
PMID: 30742570 (View on PubMed)

Jones AG, Hattersley AT. The clinical utility of C-peptide measurement in the care of patients with diabetes. Diabet Med. 2013 Jul;30(7):803-17. doi: 10.1111/dme.12159.

Reference Type RESULT
PMID: 23413806 (View on PubMed)

Uzunlulu M, Oguz A, Arslan Bahadir M, Erbakan AN, Vural Keskinler M, Alpaslan Mesci B. C-peptide concentrations in patients with type 2 diabetes treated with insulin. Diabetes Metab Syndr. 2019 Nov-Dec;13(6):3099-3104. doi: 10.1016/j.dsx.2019.11.010. Epub 2019 Nov 20.

Reference Type DERIVED
PMID: 31785503 (View on PubMed)

Other Identifiers

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C-peptide2019

Identifier Type: -

Identifier Source: org_study_id

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