Insulin SensitivityNCT07139275
Insulin Sensitivity and Testosterone Response to Aerobic Exercise Versus Added Sugar Elimination in Polycystic Ovary Syndrome Women
A study testing aerobic exercise, added sugar elimination and aerobic exercise and added sugar elimination in people with Insulin Sensitivity, run by Cairo University.
Trial summary
the aim of this study is to investigate the effect of aerobic exercise versus the effect of added sugar elimination on the insulin sensitivity and testosterone levels in females with polycystic ovarian syndrome via measuring the level of 6 hours fasting HOMA-IR and free testosterone before and after 3 months from… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- aerobic exercise, added sugar elimination and aerobic exercise and added sugar elimination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 30 Dec 2025
- Phase
- Interventional
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: sedentary overweight or obese females aged 25-40 years old with polycystic ovarian syndrome with low insulin sensitivity levels with a body mass index of 26-40 and all were diagnosed as having high, normal, or mildly elevated levels of homeostatic model assessment for insulin resistance and had none of the exclusion criteria could be included in this study.
Exclusion Criteria: patients with orthopaedic disorders that could impede the ability to walk or exercise, cardiac diseases that could interfere with their ability to exercise
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
hanaa mohamed elzoghby, lecturer at Horus university contact
About this study
the aim of this study is to investigate the effect of aerobic exercise versus the effect of added sugar elimination on the insulin sensitivity and testosterone levels in females with polycystic ovarian syndrome via measuring the level of 6 hours fasting HOMA-IR and free testosterone before and after 3 months from starting the protocol. All patients were diagnosed as polycystic ovary syndrome with low insulin sensitivity levels
Read the detailed description
In polycystic ovary syndrome the hyperandrogenic environment, in turn, promotes post-pubertal neuroendocrine dysfunction, which impairs the gonadotropin-releasing hormone (GnRH) pulse generator. This impairment leads to increased luteinizing hormone (LH) release and decreased follicle-stimulating hormone (FSH) release. These neuroendocrine unbalances support the progression to polycystic ovary syndrome, further enhancing hyperandrogenemia and ovulatory dysfunction .It is noteworthy to emphasize that IR in does not directly affect ovarian tissue. However, insulin can act as a co-gonadotropin through indirect mechanisms by enhancing luteinizing hormone (LH) action on theca cells. Additionally, insulin acts directly by inducing higher hypothalamic secretion of LH, resulting in increased production of dehydroepiandrosterone (DHEA) and androstenedione. insulin has a pleiotropic action and plays a key role not only in the regulation of metabolic homeostasis, but also in the ion and amino acid transport, in the cell proliferation, differentiation, and death, in the vascular function and inflammation, and in the neuro-hormonal activation. Abnormalities of insulin signaling transduction account for the development of insulin resistance which plays a mechanistic role in the pathogenesis of several cardiovascular risk factors such as diabetes, metabolic syndrome, hypertension, atherosclerosis, obesity, and non-alcoholic fatty liver disease (NAFLD). In addition, insulin resistance accounts also for the enhanced cardiovascular risk, and has been identified as an independent factor for the incidence of cardiovascular diseases including coronary artery disease, heart failure, and stroke. Moreover, insulin resistance negatively affects the clinical outcomes of cardiovascular and cerebrovascular diseases.
Over consuming sugar leads to fat cells that are less sensitive to the effects of insulin, which drives visceral adiposity and is a major contributor to hypertension, type 2 diabetes and heart diseases.
There is a consistent evidence that exercise training improves the baroreflex control of the sympathetic nervous system and reduces the sympathetic activity On the basis that There is a close relationship between the sympathetic nervous system and insulin sensitivity as Dysregulation of the sympathetic nervous system contributes to development of insulin resistance while Insulin stimulation increases the sympathetic nervous system activity by affecting the baroreflex sensitivity
- Conditions
- Insulin Sensitivity
- Being tested
- aerobic exercise, added sugar elimination, aerobic exercise and added sugar elimination
- Keywords
- inulin senstivity, testosterone, aerobic exercise
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
exercise protocol was applied following these characteristics (frequency: 3-5 times /week along the whole study period, intensity: 60-70% of the maximal heart rate (220- age x 60/100), duration: 50 min including warming exercise movements in standing position, active phase in form of walking on a computerized treadmill and cooling down exercise movements performed in the seated position
added sugar eliminationBehavioural
specialized programme of eliminating all kinds of added sugar (all kinds of sugars that are not naturally occurring in natural foods
aerobic exercise and added sugar eliminationCombination product
a specialized program of combining added sugar elimination protocols ( elimination of all kinds of added sugars and allowing only sugars naturally occurring in foods) combined with the same aerobic exercise protocol that applied following these characteristics (frequency: 3-5 times /week along the whole study period, intensity: 60-70% of the maximal heart rate (220- age x 60/100), duration: 50 min including warming exercise movements in standing position, active phase in form of walking on a computerized treadmill and cooling down exercise movements performed in the seated position
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise (group I) | Experimental | 20 patients performed a programme of aerobic exercise 3-5 days/ week Receives: Other: aerobic exercise |
| added sugar elimination (group II) | Experimental | 20 patients performed a programme of added sugar elimination Receives: Behavioral: added sugar elimination |
| Aerobic exercise and added sugar elimination (group III) | Experimental | 20 patients performed a programme of aerobic exercise and added sugar elimination Receives: Combination Product: aerobic exercise and added sugar elimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA- IR (homeostatic model assesment of insulin resistance)
a laboratory test for assessing the level of insulin sensitivity
Measured: test applied before and after 3 months of the interventions
free testosterone
a laboratory test that give information about the level of insulin sensitivity
Measured: before and after 3 months from the beginning of the intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Saeed Aly, Cairo University
- Investigators
- zainab saeed aly, lecturer at Horus university, Principal investigator, cairo universiyu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139275
- Sponsor's protocol ID
- P.T.REC/012/005263
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity and Testosterone Response to Aerobic Exercise Versus Added Sugar Elimination in Polycystic Ovary Syndrome Women
- ClinicalTrials.gov ID
- NCT07139275
- Acronym / sponsor ID
- P.T.REC/012/005263
- Conditions
- Insulin Sensitivity
- Keywords
- inulin senstivity, testosterone, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Aug 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.
the aim of this study is to investigate the effect of aerobic exercise versus the effect of added sugar elimination on the insulin sensitivity and testosterone levels in females with polycystic ovarian syndrome via measuring the level of 6 hours fasting HOMA-IR and free testosterone before and after 3 months from starting the protocol. All patients were diagnosed as polycystic ovary syndrome with low insulin sensitivity levels
Detailed description
In polycystic ovary syndrome the hyperandrogenic environment, in turn, promotes post-pubertal neuroendocrine dysfunction, which impairs the gonadotropin-releasing hormone (GnRH) pulse generator. This impairment leads to increased luteinizing hormone (LH) release and decreased follicle-stimulating hormone (FSH) release. These neuroendocrine unbalances support the progression to polycystic ovary syndrome, further enhancing hyperandrogenemia and ovulatory dysfunction .It is noteworthy to emphasize that IR in does not directly affect ovarian tissue. However, insulin can act as a co-gonadotropin through indirect mechanisms by enhancing luteinizing hormone (LH) action on theca cells. Additionally, insulin acts directly by inducing higher hypothalamic secretion of LH, resulting in increased production of dehydroepiandrosterone (DHEA) and androstenedione. insulin has a pleiotropic action and plays a key role not only in the regulation of metabolic homeostasis, but also in the ion and amino acid transport, in the cell proliferation, differentiation, and death, in the vascular function and inflammation, and in the neuro-hormonal activation. Abnormalities of insulin signaling transduction account for the development of insulin resistance which plays a mechanistic role in the pathogenesis of several cardiovascular risk factors such as diabetes, metabolic syndrome, hypertension, atherosclerosis, obesity, and non-alcoholic fatty liver disease (NAFLD). In addition, insulin resistance accounts also for the enhanced cardiovascular risk, and has been identified as an independent factor for the incidence of cardiovascular diseases including coronary artery disease, heart failure, and stroke. Moreover, insulin resistance negatively affects the clinical outcomes of cardiovascular and cerebrovascular diseases.
Over consuming sugar leads to fat cells that are less sensitive to the effects of insulin, which drives visceral adiposity and is a major contributor to hypertension, type 2 diabetes and heart diseases.
There is a consistent evidence that exercise training improves the baroreflex control of the sympathetic nervous system and reduces the sympathetic activity On the basis that There is a close relationship between the sympathetic nervous system and insulin sensitivity as Dysregulation of the sympathetic nervous system contributes to development of insulin resistance while Insulin stimulation increases the sympathetic nervous system activity by affecting the baroreflex sensitivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise (group I) | Experimental | Other: aerobic exercise20 patients performed a programme of aerobic exercise 3-5 days/ week |
| added sugar elimination (group II) | Experimental | Behavioral: added sugar elimination20 patients performed a programme of added sugar elimination |
| Aerobic exercise and added sugar elimination (group III) | Experimental | Combination Product: aerobic exercise and added sugar elimination20 patients performed a programme of aerobic exercise and added sugar elimination |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| aerobic exerciseexercise protocol was applied following these characteristics (frequency: 3-5 times /week along the whole study period, intensity: 60-70% of the maximal heart rate (220- age x 60/100), duration: 50 min including warming exercise movements in standing position, active phase in form of walking on a computerized treadmill and cooling down exercise movements performed in the seated position | Other | Aerobic exercise (group I) |
| added sugar eliminationspecialized programme of eliminating all kinds of added sugar (all kinds of sugars that are not naturally occurring in natural foods | Behavioural | added sugar elimination (group II) |
| aerobic exercise and added sugar eliminationa specialized program of combining added sugar elimination protocols ( elimination of all kinds of added sugars and allowing only sugars naturally occurring in foods) combined with the same aerobic exercise protocol that applied following these characteristics (frequency: 3-5 times /week along the whole study period, intensity: 60-70% of the maximal heart rate (220- age x 60/100), duration: 50 min including warming exercise movements in standing position, active phase in form of walking on a computerized treadmill and cooling down exercise movements performed in the seated position | Combination product | Aerobic exercise and added sugar elimination (group III) |
Primary outcome
HOMA- IR (homeostatic model assesment of insulin resistance)
Time frame: test applied before and after 3 months of the interventions
a laboratory test for assessing the level of insulin sensitivity
free testosterone
Time frame: before and after 3 months from the beginning of the intervention protocol
a laboratory test that give information about the level of insulin sensitivity
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 24 Aug 2025.
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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.
hanaa mohamed elzoghby, lecturer at Horus university contact
zainab saeed aly, lecturer at Horus university principal investigator
cairo universiyu
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, added sugar elimination and aerobic exercise and added sugar elimination in people with Insulin Sensitivity, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Zainab saeed aly, lecturer at Horus university (01003859679 ext. 01285512452, zaly@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA- IR (homeostatic model assesment of insulin resistance) (time frame: test applied before and after 3 months of the interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.