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

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.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IMU Goztepe Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

C-peptide concentrations

Diagnostic Test

The patients will be grouped by their C-peptide concentrations

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Goztepe Training and Research Hospital

Other

Registry information

Official study title

Is it Time to Revise Type 2 Diabetes Treatment: C-peptide Concentrations in Type 2 Diabetes Treated With Insulin

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 2, 2019
Registry last updated: Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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