Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Abdominal fat Abdominal fat
研究概览
简要总结
The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. The secondary aim of this study was to explore the effects of six-month regular moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.
详细描述
In recent years, more attention has been paid to the role of aerobic exercise in improving cognitive ability, but there is still a lack of prospective studies on the T2DM population with normal cognitive function. Therefore, the purpose of this study is to compare the differences of cognitive function and hippocampal volume between exercise group and non-exercise group by regular moderate-intensity aerobic exercise intervention for one year in T2DM patients with normal cognitive function to evaluate the impact of aerobic exercise on cognitive function and hippocampal volume for these patients and provide scientific evidence for early prevention and delaying the occurrence of cognitive dysfunction in patients with T2DM. Pancreatic fat deposition in patients with type 2 diabetes is not only a simple fat accumulation but also an early marker of insulin resistance. In this study, The effectiveness of six months of an aerobic exercise intervention on pancreas fat reduction for type 2 diabetes patients was examed.
In this study, 106 T2DM patients who met the inclusion criteria were enrolled and randomized into two groups. All patients received diabetes education(once a month, the course will be focused on basic knowledge of diabetes, diet management, and blood glucose monitoring). The control group followed their regular lifestyle without exercise intervention and recorded 24-hour dietary intake. The aerobic training group was supervised by the trainers who had received professional training and given 60min moderate aerobic rhythmic exercise (including 5min warm-up, 50min aerobic exercise, and 5min stretching exercise).
Baseline assessment included demographic data, duration of diabetes, body mass index（BMI）, waist circumference（WC）, hip circumference（HC）, systolic blood press（SBP）, diastolic blood press（DBP）, smoking and drinking, drug use, acute and chronic complications of diabetes, other chronic complications, 24-hour diet review, international physical activity questionnaire (IPAQ).
Evaluation after 6 months of intervention included pancreatic fat content(PFC), liver fat content (LFC), visceral adipose tissue (VAT), subcutaneous adipose tissue(SAT), fasting plasma glucose (FPG), 2-hour postprandial blood glucose(2hPG), hemoglobin A1c(HbA1c), fasting insulin (FINS), homeostasis model assessment of insulin resistance(HOMA2-IR), homeostasis model assessment of Beta-cell function (HOMA2-β), early insulin secretion index(Δ I30 / Δ G30), total cholesterol(TC), triglycerides(TG),high-density-lipoprotein-cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C). The Framingham cardiovascular risk scale (Framingham) and 10-year ischemic cardiovascular disease risk assessment (ICVD) scores were calculated.
Evaluation after 12 months of intervention included fasting plasma glucose(FPG),30 minutes postprandial glucose(30minPG), 2-hour postprandial glucose(2hPG)，hemoglobin A1c(HbA1c), fasting insulin(FINS),30 minutes Insulin(30minINS), homeostasis model assessment of insulin resistance(HOMA2-IR),homeostasis model assessment of Beta cell function(HOMA2-β),early insulin secretion index(Δ I30 / Δ G30),totalcholesterol(TC),triglycerides(TG),high-density-lipoprotein cholesterol( HDL-c），low-density-lipoprotein cholesterol(LDL-c),muscle mass, right, left hippocampal volume of hippocampal volume, the hippocampal volume, and total physical activity energy expenditure, total moderate physical activity energy expenditure. In addition to this, cognitive function (MMSE, MoCA) were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed of T2DM based on the 1999 diagnostic criteria of the WHO;
- •Had normal muscle strength; 3.18.5≤BMI≤35kg/m2;
- •4.Had normal cognitive function ( MMSE ≥27 points, MoCA ≥26 points) ; 5.Primary school education or above ( Participants were able to fill in the scale) ; 6.Aged 60-75 years; 7.Had ≥5 years duration of T2DM; 8.Had no evidence of hearing or visual impairment and communication difficulties; 9.Were willing to participate in the study and signed informed consent voluntarily.
排除标准
- •With severe acute complications of diabetes;
- •Serious heart, liver and kidney dysfunction, and cardiovascular and cerebrovascular diseases, such as cerebral infarction, cerebral hemorrhage, etc.;
- •Pregnant and lactating women;
- •Sleep disorders (PSQI >7 points);
- •Had a family history of dementia;
- •Alcohol dependence and oral medications that affect cognitive function (such as antipsychotic drugs, sedative hypnotics, etc.);
- •Contraindications for MRI, such as metal implant in the body.
研究组 & 干预措施
Aerobic training group
The aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months.
干预措施: Aerobic training (Behavioral)
Control group
Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education.
Intervention group
The intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year.
干预措施: Aerobic training (Behavioral)
Compared group
The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse.
结局指标
主要结局
Abdominal fat Abdominal fat
时间窗: 6 months
Pancreatic fat content（PFC,%）
Cognitive function scale(1)
时间窗: 12 months
Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;\< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and \< 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
Cognitive function scale(2)
时间窗: 12 months
The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; \< 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
Brain functional structure---Hippocampal volume
时间窗: 12 months
Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.
次要结局
- Glycemic control(1)(12 months)
- Blood lipids(12 months)
- Other abdominal fat(1)(6 months)
- Glycemic control(2)(Time Frame: 12 months)
- Hemoglobin A1c(12 months)
- HOMA2-IR and HOMA2-β(12 months)
- Other abdominal fat(2)(6 months)
- Other abdominal fat(3)(6 months)
- The Framingham Cardiovascular Risk Scale(6 months)
- The international physical activity questionnaire(6 months)
- The 10-year risk assessment table for Ischemic cardiovascular disease(6 months)
研究者
Lou Qingqing
Director of Health Education Department
Nanjing University of Traditional Chinese Medicine