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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04005261
Enrollment
249
Registered
2019-07-02
Start date
2018-11-01
Completion date
2019-03-01
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTC-peptide concentrations

The patients will be grouped by their C-peptide concentrations

Sponsors

Goztepe Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations3 monthsFasting 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 findings3 monthsCorrelations of fasting C-peptide concentrations with patients characteristics and biochemical findings, especially the components of metabolic syndrome.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026