Study of the Association of Muscle Strength, Balance and Other Factors With Vitamin Levels Among Elderly Diabetics

NCT03376490 | Completed

• 1 other identifier: awee1
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin B12 deficiency can cause severe problems with the blood, nerves, brain and psychological well-being. Ironically, our modern methods for the control of diabetes mellitus can actually contribute to vitamin B12 deficiency. This is because the diabetic medication "metformin", low-cholesterol diets lacking in meats (a natural source of vitamin B12) and the use of powerful anti-gastric medication can all reduce the natural absorption of vitamin B12 from the diet, especially in elderly people with diabetes. There is both a high prevalence of vitamin B12 deficiencies and falls among the elderly with type 2 diabetes mellitus and the investigators hypothesize that B12 deficiency contributes directly and significantly to falls in elderly diabetics through impaired muscle strength, gait and balance. This study therefore proposes to investigate the association between vitamin B12 deficiency and fall risk among diabetic elderly patients (older than 65 years) in the polyclinic setting by assessing muscle strength, balance and walking speed. The predictors of vitamin B12, folate, homocysteine and vitamin D levels will also be explored in this study. If the hypothesis is right, this would be of public health importance \& can lead to further studies that can change the way we treat diabetes by reducing falls in our elderly diabetics through the screening for, prevention and treatment of B12 deficiency.

Conditions

Muscle Strength; Vitamin B 12 Deficiency; Folate Deficiency; Vitamin D Deficiency; Hyperhomocysteinemia; Fall

Outcome Measures

Primary Outcomes (2)

• Muscle strength (Hand-grip)

  Hand-grip strength in kg force as measured by the JAMAR dynamometer .

  At recruitment

• Muscle strength (Leg extension)

  Leg strength in kg force as measured by a leg dynamometer.

  At recruitment

Secondary Outcomes (12)

• Falls

  At recruitment

• Gait speed

  At recruitment

• Gait speed

  At recruitment

• Gait speed

  At recruitment

• Balance

  At recruitment

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: stratified sampling to ensure equal number of men and women in the study. So 23 men and 23 women recruited in total.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community-living elderly patients \> 65 years of age receiving primary care from the polyclinic for the treatment of type 2 diabetes mellitus for at least a year.

You may qualify if:

• All Diabetic Adults \> 65 years old who have been on follow-up at the Polyclinic for \> 1 year; with Informed Consent.

You may not qualify if:

• Patients not fitting the Eligibility Criteria
• Inability to walk despite assistive devices because of musculoskeletal disorders \&/or
• Acute or Terminal Illness \&/or
• Documented severe Disorders of the central nervous system (e.g. major stroke, Parkinson disease, dementia \& severe visual impairment) however a subject with a previous history of stroke could be included provided he/she had recovered with no cognitive impairment or other residual effects that would affect the study results.
• Inability to understand spoken questions \&/or commands
• Failure to give or withdrawal of Informed Consent
• Patients not fitting the Eligibility Criteria
• Patients who are part of the Family Physician Clinic (FPC), thus avoiding conflict of interest.

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (1)

SingHealth Polyclinics - Marine Parade Polyclinic

Singapore, 440080, Singapore

Location

Related Publications (16)

• Ministry of Social and Family Development. National survey of senior citizens, 2005. Available at: https://www.msf.gov.sg/publications/Pages/National-Survey-on-Senior-Citizens-in-Singapore-2005.aspx. Accessed on 12 Dec 2017

  BACKGROUND

• Koh WP, Wang R, Ang LW, Heng D, Yuan JM, Yu MC. Diabetes and risk of hip fracture in the Singapore Chinese Health Study. Diabetes Care. 2010 Aug;33(8):1766-70. doi: 10.2337/dc10-0067. Epub 2010 May 26.

  PMID: 20504896 BACKGROUND

• Foo CL, Chan KC, Goh HK, Seow E. Profiling acute presenting symptoms of geriatric patients attending an urban hospital emergency department. Ann Acad Med Singap. 2009 Jun;38(6):515-6.

  PMID: 19565102 BACKGROUND

• Clarke R, Refsum H, Birks J, Evans JG, Johnston C, Sherliker P, Ueland PM, Schneede J, McPartlin J, Nexo E, Scott JM. Screening for vitamin B-12 and folate deficiency in older persons. Am J Clin Nutr. 2003 May;77(5):1241-7. doi: 10.1093/ajcn/77.5.1241.

  PMID: 12716678 BACKGROUND

• Skrabal F. Syncope, falls and cobalamin deficiency in the old population. Clin Auton Res. 2004 Apr;14(2):60-6. doi: 10.1007/s10286-004-0179-x. No abstract available.

  PMID: 15095046 BACKGROUND

• Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. doi: 10.1159/000091824.

  PMID: 16645295 BACKGROUND

• Sallinen J, Stenholm S, Rantanen T, Heliovaara M, Sainio P, Koskinen S. Hand-grip strength cut points to screen older persons at risk for mobility limitation. J Am Geriatr Soc. 2010 Sep;58(9):1721-6. doi: 10.1111/j.1532-5415.2010.03035.x.

  PMID: 20863331 BACKGROUND

• de Jager J, Kooy A, Lehert P, Wulffele MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181.

  PMID: 20488910 BACKGROUND

• Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004 Aug;52(8):1343-8. doi: 10.1111/j.1532-5415.2004.52366.x.

  PMID: 15271124 BACKGROUND

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• Pflipsen MC, Oh RC, Saguil A, Seehusen DA, Seaquist D, Topolski R. The prevalence of vitamin B(12) deficiency in patients with type 2 diabetes: a cross-sectional study. J Am Board Fam Med. 2009 Sep-Oct;22(5):528-34. doi: 10.3122/jabfm.2009.05.090044.

  PMID: 19734399 BACKGROUND

• Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.

  PMID: 12620088 BACKGROUND

• Ng TP, Niti M, Chiam PC, Kua EH. Physical and cognitive domains of the Instrumental Activities of Daily Living: validation in a multiethnic population of Asian older adults. J Gerontol A Biol Sci Med Sci. 2006 Jul;61(7):726-35. doi: 10.1093/gerona/61.7.726.

  PMID: 16870636 BACKGROUND

• Ministry of Health S. National Health Survey, 2010. Available at: https://www.moh.gov.sg/content/moh_web/home/Publications/Reports/2011/national_health_survey2010.html. Accessed 10 Sep 2017.

  BACKGROUND

• Toh E. The Straits Times. Seniors Resilient but Many Don't Exercise http://www.healthxchange.com.sg/News/Pages/Seniors-Resilient-but-Many-Dont-Exercise.aspx Accessed 24 April 2016.

  BACKGROUND

• Wee AK. Serum folate predicts muscle strength: a pilot cross-sectional study of the association between serum vitamin levels and muscle strength and gait measures in patients >65 years old with diabetes mellitus in a primary care setting. Nutr J. 2016 Oct 18;15(1):89. doi: 10.1186/s12937-016-0208-3.

  PMID: 27756315 RESULT

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Folic Acid Deficiency; Vitamin D Deficiency; Hyperhomocysteinemia

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases

Study Officials

• ANDREW KH WEE, MCI

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Physician

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: January 1, 2012
• Primary Completion: August 31, 2014
• Study Completion: August 31, 2014
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

SG (1)