Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function, and Fatigue in Geriatric Individuals: A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Cognitive status assessment
研究概览
简要总结
This case-control study will evaluate the effects of geriatric individuals on cognitive status, physical function and fatigue. Our study aims to compare the effects of geriatric individuals with prediabetes and type 2 diabetes with healthy geriatric individuals on cognitive status, physical function and fatigue. Accordingly, the hypotheses of the study are as follows:
Hypothesis 1: Prediabetes and Type 2 Diabetes Negatively Affect Cognitive Status in Geriatric Individuals.
Hypothesis 2: Physical Function Loss is More Pronounced in Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 3: Fatigue Level Will Increase in Geriatric Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 4: There Will Be a Correlation Between the Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function and Fatigue.
Hypothesis 5: Severity of Diabetes (Prediabetes vs. Type 2 Diabetes) Will Create Differences in Cognitive, Physical and Fatigue Status.
Prediabetic, diabetic and healthy volunteers constitute the universe of the study. There will be 4 different groups in the study. These groups are; those with normal range of Hemoglobin A1c Levels (HbA1c) between 4% and 5.6% for people without diabetes (Healthy), those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance), those with 6.5% - 7.5% and those with HbA1c level above 7.5. Cognitive status, physical functions, dual task performance, motor motor and motor cognitive performances, fatigue, reaction reactions, directional skills of elderly individuals will be compared between these groups.
详细描述
Type 2 Diabetes Mellitus develops due to insulin resistance and/or decreased insulin secretion and is particularly common in the elderly population. With the aging process, metabolic changes and increased insulin resistance increase the risk of diabetes. Long-term complications of diabetes can negatively affect the quality of life in geriatric individuals with effects such as cognitive impairment, loss of physical function and fatigue. In individuals with diabetes, hyperglycemia, microvascular complications and inflammation can increase the risk of cognitive decline. This can pave the way for dementia and Alzheimer's disease. Prediabetes is a condition in which blood sugar levels are higher than normal, but not high enough to diagnose diabetes, and this is an important risk factor for Type 2 Diabetes Mellitus. Even prediabetes has been associated with deterioration in cognitive functions. Loss of muscle mass (sarcopenia) and decreased physical endurance are frequently seen in geriatric individuals with diabetes. These individuals are likely to experience mobility problems and have an increased risk of falling. Chronic fatigue is another common complication of diabetes. Hyperglycemia can affect energy metabolism and cause fatigue. Fatigue can reduce physical activity levels and worsen general health status. Based on this, the study will include 4 groups: geriatric individuals with prediabetes and type 2 diabetes (controlled and uncontrolled) and healthy geriatric individuals. It will be compared whether there are any differences between these groups in terms of cognitive status, reaction times, sense of direction, dual task performance, physical function and fatigue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for people without diabetes (healthy), those with Hemoglobin A1c Levels (HbA1c) normal range between 4% and 5.6%,
- •those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance),
- •those with 6.5% -7.5% level and
- •those with HbA1c level above 7.5
- •criteria are being 60 years of age and older,
排除标准
- •those who have major depression,
- •uncontrolled thyroid disease,
- •those with vitamin B12, folic acid deficiency and anemia,
- •those with uncontrolled hypertension,
- •those with nephropathy and retrophy,
- •those with any neuropsychological disorder, a history of alcohol, substance or drug addiction,
- •those using any neurological or psychological medication (anticonvulsant drugs, antidepressants, anxiolytics, etc.),
- •those with Alzheimer's and Parkinson's disease,
- •those with cancer,
- •those with lung disease
结局指标
主要结局
Cognitive status assessment
时间窗: At the time of enrollment
The cognitive status of elderly individuals will be assessed with the Montreal Cognitive Assessment test. MoCA is a neuropsychological test developed to assess mild cognitive impairment (MCI) and early-stage dementia. It is evaluated out of 30 points and a score of 26 and above is considered normal. Validity and reliability in Turkish have been performed.
次要结局
- Assessing sense of direction.(At the time of enrollment)
- Reaction evaluation(At the time of enrollment)
- Assessment of Blood glucose(At the time of the enrollment)
- Assessment of Cortisol (µg/dL)(At the enrollment)
- Dual task performance assessment(At the time of enrollment)
- Physical Function Assessment(At the time of enrollment)
- Self-report assessment of fatigue(At the time of enrollment)
- Assessment of Hemoglobin level(At the time of enrollment)
- Assessment of Serum ferritin(At the time of enrollment)
- Assessment of Thyroid stimulating hormone (TSH)(At the time of enrollment)
- Assessment of C-reactive protein (CRP)(At the time of enrollment)
研究者
Kevser Gürsan
Principal Investigator
Uşak University