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

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ClinicalTrials.gov Identifier: NCT03376490
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
Andrew Wee Kien Han, SingHealth Polyclinics

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.

Condition or disease
Muscle Strength Vitamin B 12 Deficiency Folate Deficiency Vitamin D Deficiency Hyperhomocysteinemia Fall

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study of the Association of Muscle Strength, Tinetti Test (POMA) Scores and Other Predictor Variables With Serum Vitamin Levels (Vitamin B12, Vitamin D and Folate) in Elderly Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : August 31, 2014
Actual Study Completion Date : August 31, 2014

Primary Outcome Measures :
  1. Muscle strength (Hand-grip) [ Time Frame: At recruitment ]
    Hand-grip strength in kg force as measured by the JAMAR dynamometer .

  2. Muscle strength (Leg extension) [ Time Frame: At recruitment ]
    Leg strength in kg force as measured by a leg dynamometer.

Secondary Outcome Measures :
  1. Falls [ Time Frame: At recruitment ]
    Self-reported falls in the 12 months preceding the recruitment into the study

  2. Gait speed [ Time Frame: At recruitment ]
    Tinetti performance-oriented mobility assessment -Gait score (POMA G, Maximum score of 12)

  3. Gait speed [ Time Frame: At recruitment ]
    6-metre gait speed (m/s)

  4. Gait speed [ Time Frame: At recruitment ]
    Timed-up-and-go test (s)

  5. Balance [ Time Frame: At recruitment ]
    Tinetti performance-oriented mobility assessment -Balance score (POMA B , Maximum score of 16)

  6. Neuropathy [ Time Frame: At recruitment ]
    Vibration perception threshold using a neurothesiometer (volts)

  7. Activity of daily living [ Time Frame: At recruitment ]
    Barthel index of activity of daily living (maximum score of 20)

  8. Instrumental Activity of daily living [ Time Frame: At recruitment ]
    Lawton instrumental activities o daily living (maximum score of 8)

  9. Vitamin B12 deficiency [ Time Frame: At recruitment ]
    serum vitamin B12 levels < 150pmol/L

  10. Folate deficiency [ Time Frame: At recruitment ]
    serum folate levels < 13.5 nmol/L

  11. Hyperhomocysteinemia [ Time Frame: At recruitment ]
    serum homocysteine = or > 15 umol/L

  12. Vitamin D deficiency [ Time Frame: At recruitment ]
    serum 25-OH vitamin D < 49.9 nmol/L

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   stratified sampling to ensure equal number of men and women in the study. So 23 men and 23 women recruited in total.
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376490

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SingHealth Polyclinics - Marine Parade Polyclinic
Singapore, Singapore, 440080
Sponsors and Collaborators
SingHealth Polyclinics
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Principal Investigator: ANDREW KH WEE, MCI SingHealth Polyclinics
Publications of Results:
Other Publications:
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
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.
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.

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Responsible Party: Andrew Wee Kien Han, Family Physician, SingHealth Polyclinics
ClinicalTrials.gov Identifier: NCT03376490    
Other Study ID Numbers: awee1
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plans are being made to share the de-identified data. However, the exact portal with which to share the data has not been decided upon and various options are being considered currently. Meanwhile, datasets are available form the principal investigator on reasonable request and with permission from the SingHealth Centralized Institutional Review Board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Vitamin B 12 Deficiency
Folic Acid Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin B Deficiency
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases