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出境医 / 临床实验 / C-peptide Concentrations in Type 2 Diabetes Treated With Insulin; is it Time to Revise the Treatment of Type 2 Diabetes

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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)
Contacts and Locations

Locations
Layout table for location information
Turkey
IMU Goztepe Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Goztepe Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ayşe N Erbakan, MD IMU Doctoral program
Study Director: Mehmet Uzunlulu, Prof IMU Goztepe Education and Research Hospital
Tracking Information
First Submitted Date June 28, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date November 1, 2018
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title C-peptide Concentrations in Type 2 Diabetes Treated With Insulin; is it Time to Revise the Treatment of Type 2 Diabetes
Official Title Is it Time to Revise Type 2 Diabetes Treatment: C-peptide Concentrations in Type 2 Diabetes Treated With Insulin
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Type 2 Diabetes Treated With Insulin
Intervention Diagnostic Test: C-peptide concentrations
The patients will be grouped by their C-peptide concentrations
Study Groups/Cohorts 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

Intervention: Diagnostic Test: C-peptide concentrations
Publications *
  • 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. Review.
  • 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. Erratum in: Diabetes. 2004 Jul;53(7):1934.
  • 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. Review.
  • 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. Erratum in: Endocr Pract. 2019 Feb;25(2):204.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2019) 		249
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005261
Other Study ID Numbers C-peptide2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ayse N Erbakan, Goztepe Training and Research Hospital
Study Sponsor Goztepe Training and Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ayşe N Erbakan, MD IMU Doctoral program
Study Director: Mehmet Uzunlulu, Prof IMU Goztepe Education and Research Hospital
PRS Account Goztepe Training and Research Hospital
Verification Date July 2019

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