Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause

NCT06806345 | Recruiting Phase 1

• 1 other identifier: 012/004726
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance Syndrome

Outcome Measures

Primary Outcomes (3)

• HgA1c

  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%.

  two months

• Function

  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 .

  two months

• fasting blood glucose level

  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.

  every 10 sessions for 2months

Study Arms (2)

hyperbaric oxygen therapy group

EXPERIMENTAL

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)

Device: Hyperbaric oxygen therapy; Drug: Hypoglycemic Drug

control group

OTHER

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

Drug: Hypoglycemic Drug

Interventions

Hyperbaric oxygen therapy 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,

hyperbaric oxygen therapy group

Hypoglycemic Drug 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; hyperbaric oxygen therapy group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kobry el koba military complex

Cairo, Cairo Governorate, 3753450, Egypt

RECRUITING

Related Publications (3)

• 79, 1335-1340

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Hyperbaric Oxygenation; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Siham mohamed fahmy Head of Hyperbaric oxygen therapy unit, Assistant professor

CONTACT

01033380185; Fahmysiham@gmail.com

Kobry el koba military complex Kobry el koba military complex, Military Medical complex

CONTACT

0222638885; info@KobryKobba.com.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 4, 2025
• Study Start: January 28, 2025
• Primary Completion: March 28, 2025
• Study Completion: April 28, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)