Insulin Sensitivity and Testosterone Response to Aerobic Exercise Versus Added Sugar Elimination in Polycystic Ovary Syndrome Women
1 other identifier
interventional
60
0 countries
N/A
Brief 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 starting the protocol. All patients were diagnosed as polycystic ovary syndrome with low insulin sensitivity levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedAugust 24, 2025
August 1, 2025
4 months
August 17, 2025
August 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HOMA- IR (homeostatic model assesment of insulin resistance)
a laboratory test for assessing the level of insulin sensitivity
test applied before and after 3 months of the interventions
free testosterone
a laboratory test that give information about the level of insulin sensitivity
before and after 3 months from the beginning of the intervention protocol
Study Arms (3)
Aerobic exercise (group I)
EXPERIMENTAL20 patients performed a programme of aerobic exercise 3-5 days/ week
added sugar elimination (group II)
EXPERIMENTAL20 patients performed a programme of added sugar elimination
Aerobic exercise and added sugar elimination (group III)
EXPERIMENTAL20 patients performed a programme of aerobic exercise and added sugar elimination
Interventions
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
Eligibility Criteria
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Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zainab saeed aly, lecturer at Horus university
cairo universiyu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 24, 2025
Study Start
August 20, 2025
Primary Completion
December 20, 2025
Study Completion
December 30, 2025
Last Updated
August 24, 2025
Record last verified: 2025-08