Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy

NCT05394571 | Completed DMC

• 1 other identifier: Poorly controlled T2DM
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. We aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 3 months.

Conditions

Type 2 Diabetes; Poorly Controlled Diabetes Mellitus

Keywords

type 2 diabetes; poorly controlled Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Changes in HbA1c levels after 3 months treatment

  Changes in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups.

  Three months

• Changes in HbA1c levels equal to or more than 20%

  Comparison of the patient groups according to the reduction of 20% or more in HbA1c levels.

  Three months

• ratio of patients who reached the HbA1c target of equal to or below 7%

  Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%.

  Three months

Secondary Outcomes (3)

• The effect of education on the HbA1c changes

  Three months

• The effect of depression on the HbA1c changes

  Three months

• The effect of the level of physical activity on the HbA1c changes

  Three months

Study Arms (4)

Newly diagnosed diabetes

Patients who have been diagnosed with type 2 diabetes within a month

Had controlled diabetes before

Patients who had at least two HbA1c levels =\<%7,5 before enrollment

Had moderately uncontrolled diabetes

Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment

Had poorly controlled diabetes

Patients who had at least two HbA1c levels above %9,5 before enrollment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with type 2 diabetes and have an HbA1c level equal to or higher than 10%

You may qualify if:

• diagnosed with type 2 diabetes
• give consent to the study
• accessibility to the previous and recent test results

You may not qualify if:

• acute infection or inflammation lasting more than a week
• acute metabolic decompensation
• unable to attend to the follow-ups
• having non-thyroid endocrine diseases
• active oncologic treatment

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006.

  PMID: 33298417 BACKGROUND

• Walraven I, Mast MR, Hoekstra T, Jansen AP, van der Heijden AA, Rauh SP, Rutters F, van 't Riet E, Elders PJ, Moll AC, Polak BC, Dekker JM, Nijpels G. Distinct HbA1c trajectories in a type 2 diabetes cohort. Acta Diabetol. 2015 Apr;52(2):267-75. doi: 10.1007/s00592-014-0633-8. Epub 2014 Oct 8.

  PMID: 25287012 BACKGROUND

• Nichols GA, Joshua-Gotlib S, Parasuraman S. Glycemic control and risk of cardiovascular disease hospitalization and all-cause mortality. J Am Coll Cardiol. 2013 Jul 9;62(2):121-127. doi: 10.1016/j.jacc.2013.04.031. Epub 2013 May 9.

  PMID: 23665365 BACKGROUND

• Satman I, Omer B, Tutuncu Y, Kalaca S, Gedik S, Dinccag N, Karsidag K, Genc S, Telci A, Canbaz B, Turker F, Yilmaz T, Cakir B, Tuomilehto J; TURDEP-II Study Group. Twelve-year trends in the prevalence and risk factors of diabetes and prediabetes in Turkish adults. Eur J Epidemiol. 2013 Feb;28(2):169-80. doi: 10.1007/s10654-013-9771-5. Epub 2013 Feb 14.

  PMID: 23407904 BACKGROUND

• Satman I, Imamoglu S, Yilmaz C; ADMIRE Study Group. A patient-based study on the adherence of physicians to guidelines for the management of type 2 diabetes in Turkey. Diabetes Res Clin Pract. 2012 Oct;98(1):75-82. doi: 10.1016/j.diabres.2012.05.003. Epub 2012 May 29.

  PMID: 22652276 BACKGROUND

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

• Ayse N Erbakan, MD

  Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 27, 2022
• Study Start: August 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)