An interventional study of aerobic exercise and added sugar elimination in Insulin Sensitivity, sponsored by Cairo University. Not yet recruiting. Open to female participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
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
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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
20 patients performed a programme of aerobic exercise 3-5 days/ week
Other: aerobic exercise
20 patients performed a programme of added sugar elimination
Behavioral: added sugar elimination
20 patients performed a programme of aerobic exercise and added sugar elimination
Combination Product: aerobic exercise and added sugar elimination
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
specialized programme of eliminating all kinds of added sugar (all kinds of sugars that are not naturally occurring in natural foods
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
HOMA- IR (homeostatic model assesment of insulin resistance)
a laboratory test for assessing the level of insulin sensitivity
Time frame: test applied before and after 3 months of the interventions
free testosterone
a laboratory test that give information about the level of insulin sensitivity
Time frame: before and after 3 months from the beginning of the intervention protocol
No study locations are listed for this record.
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Cairo University