Effect of Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HgA1c
研究概览
简要总结
Background: In postmenopausal females, Insulin resistance is commonly encountered in clinical setting. Hyperbaric oxygen therapy have been proposed effective in lowering blood glucose level and improving function. Identification of clinical examination variables as predictors to blood glucose levels and dysfunction would offer therapists the chance to undertake clinical decisions and consequently improve treatment efficiency.
Objectives: This Predictive validity, diagnostic study conduct to examine the effect of hyperbaric oxygen therapy on insulin resistance in postmenopausal women.
详细描述
Purpose of the study:
The purpose of the current study is to determine if Hyperbaric oxygen therapy will have an effect on the treatment of post menopausal insulin resistance?
Significance of the study:
Insulin resistance along with Type2 diabetes (T2DM) is now considered an emerging clinical and public health problem in Egypt. Atherosclerotic cardiovascular diseases are the major causes of morbidity and mortality in diabetic patients (Soliman ,2008).
Persistent high glucose level leads to chronic damages and dysfunctions of various tissues, especially in the heart, blood vessel, eye, and kidney, causing a series of chronic complications. These complications(microvascular and macrovascular) are the major cause of disability in diabetic patients and has already been aserious social health. Thus, prevention and alleviation of the vascular complications has become a major challenge in diabetes therapy problem (Wang et al.,2015).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A)Inclusion Criteria
- •All females were clinically diagnosed with Postmenopausal Insulin resistance.
- •Their ages were ranged from 55-65 years old.
- •Their BMI was 30-34.9 kg/m².
- •All patients should had controlled blood glucose levels by oral hypoglycemic drugs.
- •All patients should had cardiac Ejection Fraction >or =50%.
- •Their Chest X-ray reported normal.
- •Their Ear ,nose , thorax will be clinically evaluated by a specialized ENT physician to ensure fitting for hyperbaric chamber
- •Voluntary acceptance of participation in the study .
排除标准
- •Participants will be excluded if they have :
- •Chronic obstructive pulmonary disease.
- •Cardiac pacemakers.
- •Epileptic fits.
- •Physically disable .
- •Any disorder that lead to ulcers other than diabetes such as ahistory of chronic peripheral arterial disease.
- •Exclusion Criteria:
研究组 & 干预措施
hyperbaric oxygen therapy group
Hyperbaric Oxygen Therapy (HBOT): It was applied for Group (A) started with a gradual increase of oxygen pressure to be approximately 2.5 ATA through 15 min in a100% oxygen delivered for 60 min Then, gradual decompression through 15 min for a total of 90min per each session for 30 sessions (5 sessions per week for 6weeks)
干预措施: Hypoglycemic Drug (Drug)
control group
Hypoglycemic drug 'Metformin' Metformin reduces serum glucose level by several different mechanisms without increasing insulin secretion.it increases the effects of insulin so it is termed "insulin sensitizer ,metformin also suppresses the endogenous glucose production by the liver ,which is mainly due to a reduction in the rate of gluconeogenesis and asmall effect on glycogenolysis. Moreover, metformin activates the enzyme adenosine monophosphate kinase (AMPK) resulting in the inhibition of key enzymes involved in gluconeogenesis and glycogen synthesis in the liver while stimulating insulin signaling and glucose transport in muscles 500 mg once per day
干预措施: Hypoglycemic Drug (Drug)
hyperbaric oxygen therapy group
Hyperbaric Oxygen Therapy (HBOT): It was applied for Group (A) started with a gradual increase of oxygen pressure to be approximately 2.5 ATA through 15 min in a100% oxygen delivered for 60 min Then, gradual decompression through 15 min for a total of 90min per each session for 30 sessions (5 sessions per week for 6weeks)
干预措施: Hyperbaric oxygen therapy (Device)
结局指标
主要结局
HgA1c
时间窗: two months
the glycated hemoglobin (HbA1c) level determines the ability of the body to control the glycemic level over the last 2-3 months, According to ADA, the HbA1C level for a normal subject is \<5.7% and for adiabetic patient is \>or=6.5%.
Function
时间窗: two months
Quality of life enjoyment satisfaction and questionnaire (QLES-QSFB): It consists of items that evaluate overall enjoyment and satisfaction regarding ; Physical Health, mood, work, household and leisure activities, family and social relationships, ability to function in daily life , economic status , living or housing situation , ability to get around physically, ability to do work or hobbies, and overall sense of being. The Q-LES-Q-SF is a validated, self reported evaluation of the degree to which enjoyment and satisfaction are derived from various areas of life . Responses were scored on a five point scale ( from "very poor" to " very good " ) , where higher scores indicate better enjoyment and satisfaction with life . Scores were added and presented as a percentage of the total maximum score . A percentage of total score of \> 70 represents normal quality of life .
fasting blood glucose level
时间窗: every 10 sessions for 2months
The patients fasted for at least 8 hours. Measurements were done by blood glucose meter, a lancet device with lancets and test strips. The finger was picked with the lancet to obtain a very small drop of blood which was applied to a test strip placed in the meter.
次要结局
未报告次要终点
研究者
Sherin Mohamed Samy Abdel Ghany Basha
Assistant lecturer
Cairo University