Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause
ConditionInsulin Resistance Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age55-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Chronic obstructive pulmonary disease.
Cardiac pacemakers.
Epileptic fits.
Physically disable .
Trial design
Design model
Parallel
Treatments tested in this trial
Hyperbaric oxygen therapy
DeviceHyperbaric 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
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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: hyperbaric oxygen therapy groupExperimental treatment 2 interventions
Group B: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
two months2
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 .
Time frame
two months3
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.
Time frame
every 10 sessions for 2monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov