Insulin Resistance SyndromePhase 1/2NCT06806345
Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause
A Phase 1/2 study testing Hyperbaric oxygen therapy and Hypoglycemic Drug in people with Insulin Resistance Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Insulin Resistance Syndrome
- What is being tested?
- Hyperbaric oxygen therapy and Hypoglycemic Drug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2025to 28 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Show all 16Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Siham mohamed fahmy Head of Hyperbaric oxygen therapy unit, Assistant professor contact
Kobry el koba military complex Kobry el koba military complex, Military Medical complex contact
Egypt1 site, 1 recruiting
- Recruiting
Kobry el koba military complex
Cairo, Cairo Governorate, 3753450
kobry el koba military complex kobry el koba military complex, Military hospital, 0222638885 ext. 0222639393, info@KobryKobba.com.eg
Sohier Mahmoud El Kosery Head of Women health department faculty of physical therapy, Professor at Cairo university
About this study
Official title: Effect of Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopausal Women
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.
Read the 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)
- Conditions
- Insulin Resistance Syndrome
- Being tested
- Hyperbaric oxygen therapy, Hypoglycemic Drug
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
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 DrugDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Hypoglycemic Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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 .
Measured: 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.
Measured: every 10 sessions for 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start28 Jan 2025 (estimated)
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin Resistance SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherin Mohamed Samy Abdel Ghany Basha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806345
- Sponsor's protocol ID
- 012/004726
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 31002414Abildgaard 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.
PubMed 32574226
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06806345
- Acronym / sponsor ID
- 012/004726
- Conditions
- Insulin Resistance Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Jan 2025 (estimated)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy group | Experimental | Device: Hyperbaric oxygen therapy, Drug: Hypoglycemic DrugHyperbaric 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) |
| control group | Other | Drug: Hypoglycemic DrugHypoglycemic 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 |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A)Inclusion Criteria
- Chronic obstructive pulmonary disease.
- Cardiac pacemakers.
- Epileptic fits.
- Physically disable .
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyHyperbaric 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, | Device | hyperbaric oxygen therapy group |
| Hypoglycemic DrugMetformin 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 | Drug | control group, hyperbaric oxygen therapy group |
Primary outcome
HgA1c
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background79, 1335-1340
- Results publication: PubMed 31002414Golledge 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.
- Results publication: PubMed 32574226Abildgaard 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siham mohamed fahmy Head of Hyperbaric oxygen therapy unit, Assistant professor contact
Kobry el koba military complex Kobry el koba military complex, Military Medical complex contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperbaric oxygen therapy and Hypoglycemic Drug in people with Insulin Resistance Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siham mohamed fahmy Head of Hyperbaric oxygen therapy unit, Assistant professor (01033380185, Fahmysiham@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HgA1c (time frame: two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806345, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.