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

NCT04005261 | Completed

• 1 other identifier: C-peptide2019
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetes; C-peptide; beta-cell reserve; insulin use

Outcome Measures

Primary Outcomes (2)

• The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations

  Fasting C-peptide concentrations will be measured in patients with type 2 diabetic patients using insulin as a monotherapy or as part of combination therapy and the patients will be grouped as patients with adequate beta cell reserves, patients with borderline beta cell reserves and patient with insufficient beta cell reserves.

  3 months

• Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings

  Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings, especially the components of metabolic syndrome.

  3 months

Study Arms (1)

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

Diagnostic Test: C-peptide concentrations

Interventions

C-peptide concentrations DIAGNOSTIC_TEST

The patients will be grouped by their C-peptide concentrations

patients with type 2 diabetes treated with insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with type 2 diabetes treated with insulin aged 18 years or older who presented to the Diabetes Outpatient Clinics of Istanbul Medeniyet University Goztepe Training and Research Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

IMU Goztepe Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 28484968 BACKGROUND

• 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.

  PMID: 14693724 BACKGROUND

• 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.

  PMID: 30559235 BACKGROUND

• 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.

  PMID: 30742570 BACKGROUND

• 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.

  PMID: 23413806 RESULT

• 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.

  PMID: 31785503 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ayşe N Erbakan, MD

  IMU Doctoral program

  PRINCIPAL INVESTIGATOR

• Mehmet Uzunlulu, Prof

  IMU Goztepe Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-07

Locations

TU (1)