Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2025-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Insulin on Post Burn Hypermetabolism

NCT00137254

Burns

COMPLETED NA

Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery

NCT01361594

Diabetes

COMPLETED PHASE3

Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital

NCT02868606

Diabetes Mellitus, Type 2 Hyperglycemia

COMPLETED

Insulin-based Strategies to Prevent Hypoglycemia During Exercise

NCT02631265

Type 1 Diabetes

COMPLETED NA

Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

NCT05822674

Type 2 Diabetes

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type DEVICE

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,

Hypoglycemic Drug

Intervention Type 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 gluconeogenesis and glycogen synthesis in the liver while stimulating insulin signaling and glucose transport in muscles

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

Group Type OTHER

Hypoglycemic Drug

Intervention Type 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 gluconeogenesis and glycogen synthesis in the liver while stimulating insulin signaling and glucose transport in muscles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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,

Intervention Type DEVICE

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 gluconeogenesis and glycogen synthesis in the liver while stimulating insulin signaling and glucose transport in muscles

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .

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.

\-

Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No