Study of the Association of Muscle Strength, Balance and Other Factors With Vitamin Levels Among Elderly Diabetics
|ClinicalTrials.gov Identifier: NCT03376490|
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 19, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Observational Model:||Ecologic or Community|
|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|
- Muscle strength (Hand-grip) [ Time Frame: At recruitment ]Hand-grip strength in kg force as measured by the JAMAR dynamometer .
- Muscle strength (Leg extension) [ Time Frame: At recruitment ]Leg strength in kg force as measured by a leg dynamometer.
- Falls [ Time Frame: At recruitment ]Self-reported falls in the 12 months preceding the recruitment into the study
- Gait speed [ Time Frame: At recruitment ]Tinetti performance-oriented mobility assessment -Gait score (POMA G, Maximum score of 12)
- Gait speed [ Time Frame: At recruitment ]6-metre gait speed (m/s)
- Gait speed [ Time Frame: At recruitment ]Timed-up-and-go test (s)
- Balance [ Time Frame: At recruitment ]Tinetti performance-oriented mobility assessment -Balance score (POMA B , Maximum score of 16)
- Neuropathy [ Time Frame: At recruitment ]Vibration perception threshold using a neurothesiometer (volts)
- Activity of daily living [ Time Frame: At recruitment ]Barthel index of activity of daily living (maximum score of 20)
- Instrumental Activity of daily living [ Time Frame: At recruitment ]Lawton instrumental activities o daily living (maximum score of 8)
- Vitamin B12 deficiency [ Time Frame: At recruitment ]serum vitamin B12 levels < 150pmol/L
- Folate deficiency [ Time Frame: At recruitment ]serum folate levels < 13.5 nmol/L
- Hyperhomocysteinemia [ Time Frame: At recruitment ]serum homocysteine = or > 15 umol/L
- Vitamin D deficiency [ Time Frame: At recruitment ]serum 25-OH vitamin D < 49.9 nmol/L
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376490
|SingHealth Polyclinics - Marine Parade Polyclinic|
|Singapore, Singapore, 440080|
|Principal Investigator:||ANDREW KH WEE, MCI||SingHealth Polyclinics|