Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause

Official title

Effect of Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopausal Women

Overview

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.

Detailed 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)

Interventions

• Device Hyperbaric oxygen therapy
  Hyperbaric Oxygen Therapy (HBOT):(Haux, Starmed 2300, Germany). A multichamper Double-lock, divided into Main chamber and Antichamber, with omega Ω-shape and all safety and CE-Certificate,
• Drug Hypoglycemic Drug
  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 gluconeog

Primary outcome measures

• HgA1c [Time frame: two months]
• Function [Time frame: two months]
• fasting blood glucose level [Time frame: every 10 sessions for 2months]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Kobry el koba military complex — Cairo

Publications

• 79, 1335-1340
• Golledge J, Singh TP. Systematic review and meta-analysis of clinical trials examining the effect of hyperbaric oxygen therapy in people with diabetes-related lower limb ulcers. Diabet Med. 2019 Jul;36(7):813-826. doi: 10.1111/dme.13975. Epub 2019 May 26. PMID 31002414
• Abildgaard J, Tingstedt J, Zhao Y, Hartling HJ, Pedersen AT, Lindegaard B, Dam Nielsen S. Increased systemic inflammation and altered distribution of T-cell subsets in postmenopausal women. PLoS One. 2020 Jun 23;15(6):e0235174. doi: 10.1371/journal.pone.0235174. eCollection 2020. PMID 32574226

Identifiers

NCT: NCT06806345 · 012/004726

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗