Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause

Cairo University (CU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Insulin Resistance Syndrome

Treatments: Device: Hyperbaric oxygen therapy; Drug: Hypoglycemic Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT06806345

012/004726

Details and patient eligibility

About

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.

Full description

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).

Hyperglycemia associated with diabetes mellitus causes vascular disease, which is responsible for most of the morbidity, hospitalizations, and death that occur in patients. Microvascular lesions promote nephropathy, retinopathy, and neuropathy, while damage to large blood vessels increase the risk of cardiovascular events by 2 to 4 folds(Buron and Thaunat,2020).

The goal of treatment for insulin resistance in postmenopausal women are to prevent or delay complications and maintain quality of life. This require control of glycemia, cardiovascular risk factor management,and regular follow-up. Life style modifications including physical activity , healthy diet ,smoking cessation and maintaince of ahealthy body weight are recommended as first line therapies from the time of diagnosis and as co-therapy for patients who also require glucose-lowering medications (Davies et al.,2018).

Hyperbaric oxygen therapy was found to improve glycemic control,increase insulin sensitivity in overweight or obese individuals with and without T2DM and improve atherogenic metabolic changes.suggested that it could be used as a therapeutic intervention for T2DM. ( Wilkinson et al.,2015)

Enrollment: 40 estimated patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 .

B)Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

hyperbaric oxygen therapy group

Experimental group

Description:

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)

Treatment:

Drug: Hypoglycemic Drug

Device: Hyperbaric oxygen therapy

control group

Other group

Description:

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

Treatment:

Drug: Hypoglycemic Drug