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临床试验/NCT03376490
NCT03376490已完成不适用

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

SingHealth Polyclinics1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Muscle strength (Leg extension)

研究概览

简要总结

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.

详细描述

Singapore is a fast-aging Nation. A national survey of senior citizens in 2005 projected that the prevalence of persons >65 yrs. in Singapore will increase from 7.3% in 2000 to 18.7% in 2030. Moreover, 7.1% of adults from 65 to 74 years were at least dependent on walking aids for mobility and this prevalence increased to 22.3% (17.5% for Males & 26% for females) for adults aged 75 and above.

The Prevalence of Diabetes Mellitus is very high among the Elderly in Singapore. The National Health Survey in 2010 showed that almost 1 out of 3 (29.1%) of our elderly aged 60-69 have Diabetes mellitus.

In Marine Parade Polyclinic in 2007, 36.3% (i.e. more than 1/3) of our patients were aged 65 yrs. or older. Moreover, a recent (2011) study by the Ministry of Health (MOH) on 2,600 community-dwelling elderly people in Marine Parade showed that 78.4% suffer at least 1 chronic disease and 15% had fallen in the 12 months leading to the MOH Survey.

A prospective cohort study of 63,257 Singapore local Chinese showed "a very strong dose-dependent relationship between duration of diabetes and risk of hip fracture (P for trend < 0.0001" and that "prevention of falls should be part of the management of diabetes".

A study profile of 2847 Acute Presentations at the Tan Tock Seng Hospital A & E Dept. by the geriatric population showed that "Falls" was the most common presenting complaint (13.9%).

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Muscle strength (Leg extension)

时间窗: At recruitment

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

Muscle strength (Hand-grip)

时间窗: At recruitment

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

次要结局

  • Gait speed(At recruitment)
  • Balance(At recruitment)
  • Neuropathy(At recruitment)
  • Folate deficiency(At recruitment)
  • Falls(At recruitment)
  • Activity of daily living(At recruitment)
  • Instrumental Activity of daily living(At recruitment)
  • Vitamin B12 deficiency(At recruitment)
  • Vitamin D deficiency(At recruitment)
  • Hyperhomocysteinemia(At recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Wee Kien Han

Family Physician

SingHealth Polyclinics

研究点 (1)

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