NCT05203042

Brief Summary

The aim of this study is to compare the dual task task in individuals with prediabetes and diabetes. According to the results of this study, if there is a difference in dual-task performances and other conditions between people with prediabetes and people with diabetes, it will be a reference study for intervention studies accordingly.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

October 2, 2021

Last Update Submit

January 10, 2022

Conditions

Diabetes Mellitus

Keywords

DiabetesPrediabetesDouble task performance

Outcome Measures

Primary Outcomes (1)

  • Timed Get Up and Go Test-Motor and Cognitive Task:

    The timed up-and-go test is a widely used clinical test to evaluate balance and mobility. The clinical benefit of the test is that it can monitor transitions that require balance control, and mobility skills such as sitting up and walking straight. As the primary task, the participant stands up with the command "Start" from a 46cm standard height chair and walks 3 meters, then turns 180⁰ back and sits on the chair. As a secondary task, he is asked to carry a standardized glass of water without spilling it during the test. As a cognitive task, the participant stands up with the "Start" command from a 46cm standard height chair as the primary task and walks 3 meters, then turns 180⁰ back and sits on the chair. As a secondary task, he is asked to count backwards from 100 by sevens during the test. He will be allowed to practice cognitively in his seat before starting the test. The time elapsed during the test will be recorded.

    15 minutes

Secondary Outcomes (6)

  • Short Physical Performance Battery:

    10 minutes

  • Muscle Strength Measurement

    5 minutes

  • Mini Mental State Test

    10 minutes

  • Fatigue Assessment

    2 minutes

  • Pain Assessment

    2 minutes

  • +1 more secondary outcomes

Study Arms (2)

prediabetes

diabetes

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Ministry of Health, Karabük Provincial Health Directorate, Barış Family Health Center / 780520 Health Center Safranbolu / Karabük center applied to the center, Dr. Patients over the age of 65 who volunteered to participate in the study, who were followed up by Hasan Hüseyin Mermerkaya, who came on a routine basis, had a blood test within a maximum of 6 months, and were diagnosed with type 2 diabetes or prediabetes, will be included in the study.

You may qualify if:

  • be 65 years or older
  • Being diagnosed with type 2 diabetes or prediabetes
  • Volunteer to participate in the study
  • Ability to participate in tests independently
  • Getting a score of 24 or higher on the Mini Mental State Test
  • Being literate
  • Being able to communicate

You may not qualify if:

  • Cancer patients known to be life-threatening
  • Severe respiratory, central, vascular, peripheral and uncontrolled metabolic problems
  • Using drugs known to affect the postural control system (eg benzodiazepines)
  • Those with peripheral neuropathy
  • Those with severe hearing and visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. World health Organization (WHO), Diabetes Fact Sheet. Updated October 30th 2018. 2. Zhou B, Lu Y, Hajifathalian K,et al. Worldwide trends in dia- betes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet 2016; 387(10027): .1513-30. 3. Chatterjee S, Peters SAE, Woodward M, Mejia Arango SM, Batty D, Beckett N, et al. Type 2 diabetes as a risk factor for dementia in women compared with men: A pooled analysis of 2.3 million people comprising more than 100,000 cases of dementia. Diabetes Care. 2016. February; 39(2): 300-307. 4. Reyes-García R., Moreno-Pérez Ó., Tejera-Pérez C., Fernández-García D., Bellido-Castañeda V., López de la Torre Casares M., Rozas-Moreno P., Fernández-García J.C., Marco Martínez A., Escalada-San Martín J., et al. A comprehensive approach to type 2 diabetes mellitus-A recommendation document. Endocrinol. Diab. Nutric. 2019;66:443-458. doi: 10.1016/j.endinu.2018.10.010. 5. Schlienger J.-L. Complications du diabète de type 2. Presse Med. 2013;42:839-848. doi: 10.1016/j.lpm.2013.02.313. 6. Diabetes Association of the Republic of China (Taiwan) Executive summary of the DAROC clinical practice guidelines for diabetes care-2018. J. Formos. Med. Assoc. 2019 doi: 10.1016/j.jfma.2019.02.016. 7. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. Atlanta: US Department of Health and Human Services; 2014, International Diabetes Federation IDF diabetes atlas 2015. 7th. Brussels: International Diabetes Federation; 2015. 8. Middelbeek RJW, Abrahamson MJ. Diabetes, prediabetes, and glycemic control in the United States: challenges and opportunities. Ann Intern Med. 2014;160:572-573. 9. Forouhi N, Luan J, Hennings S, Wareham N. Incidence of Type 2 diabetes in England and its association with baseline impaired fasting glucose: the Ely study 1990-2000. Diabetic medicine. 2007;24(2):200-7., Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Pratley R, et al. Impaired fasting glucose and impaired glucose tolerance. Diabetes care. 2007;30(3):753-9. 10. Hu D, Fu P, Xie J, et al. MS for the InterASIA Collaborative Group Increasing prevalence and low awareness, treatment and control of diabetes mellitus among Chinese adults: the InterASIA study. Diabetes Res Clin Pract. 2008;81:250-257. 11. Brannick B, Wynn A, Dagogo-Jack S. Prediabetes as a toxic environment for the initiation of microvascular and macrovascular complications. Exp Biol Med (Maywood) 2016;241:1323-1331. 12. Tuligenga RH, Dugravot A, Tabak AG, et al. Midlife type 2 diabetes and poor glycaemic control as risk factors for cognitive decline in early old age: a post-hoc analysis of the Whitehall II cohort study. Lancet Diabetes Endocrinol. 2014;2:228-235. doi: 10.1016/S2213-8587(13)70192-X. 13. Alosco ML, Gunstad J. The negative effects of obesity and poor glycemic control on cognitive function: a proposed model for possible mechanisms. Curr Diab Rep. 2014. June; 14(6): 495 10.1007/s11892-014-0495. 14. Munshi M, Capelson R, Grande R, Lin S, Hayes M, Milberg W, et al. Cognitive dysfunction is associated with Poor Diabetes Control in Older Adults. Diabetes Care, 2006. August; 29(8): 1794-1799. 10.2337/dc06-0506. 15. Koekkoek PS, Kappelle LJ, van den Berg E, Rutten GE, Biessels GJ. Cognitive function in patients with diabetes mellitus: guidance for daily care. Lancet Neurol. 2015. March; 14(3): 329-340. 10.1016/S1474-4422(14)70249-2. 16. Roriz-Filho S.Sa-Roriz T.M.Rosset I.et al.(Pre)diabetes, brain aging, and cognition.Biochim Biophys Acta. 2009; 1792: 432-443. 17. Woollacott M, Shumway-Cook A. Attention and the control ofposture and gait: a review of an emerging area of research. GaitPosture 2002; 16(1): 1-14. 18. Wollacott M, Shumway-Cook A. Attention and the control of posture and gait; a review of an emerging area of research. Gait Posture 2002; 16: 1- 14. 19. Villafaina S., Collado-Mate D., Domínguez-Muñoz F.J., Fuentes-García J.P., Gusi N. Impact of adding a cognitive task while performing physical fitness tests in women with fibromyalgia: A cross-sectional descriptive study. Medicine (Baltimore) 2018;97:e13791. 20. Omana H, Madou E., Montero-Odasso et all. The Effect of Dual-Task Testing on Balance and Gait Performance in Adults with Type 1 or Type 2 Diabetes Mellitus: A Systematic Review., Current Diabetes ReviewsBentham science Publishers, Current Diabetes Reviews, 2020, Vol.16, no.1-0.

    BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Gizem GM MERMERKAYA

CONTACT

+905455850238gizmyagiz@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 2, 2021

First Posted

January 24, 2022

Study Start

January 15, 2022

Primary Completion

March 15, 2022

Study Completion

March 30, 2022

Last Updated

January 24, 2022

Record last verified: 2022-01