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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005261
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ayse N Erbakan, Goztepe Training and Research Hospital

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Treated With Insulin Diagnostic Test: C-peptide concentrations

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Is it Time to Revise Type 2 Diabetes Treatment: C-peptide Concentrations in Type 2 Diabetes Treated With Insulin
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
The patients will be grouped by their C-peptide concentrations




Primary Outcome Measures :
  1. The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations [ Time Frame: 3 months ]
    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.

  2. Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings [ Time Frame: 3 months ]
    Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings, especially the components of metabolic syndrome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005261


Locations
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Turkey
IMU Goztepe Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Goztepe Training and Research Hospital
Investigators
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Principal Investigator: Ayşe N Erbakan, MD IMU Doctoral program
Study Director: Mehmet Uzunlulu, Prof IMU Goztepe Education and Research Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayse N Erbakan, Principal Investigator, Goztepe Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04005261    
Other Study ID Numbers: C-peptide2019
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayse N Erbakan, Goztepe Training and Research Hospital:
Type 2 diabetes
C-peptide
beta-cell reserve
insulin use
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases