NCT07139275

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Completed
3 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 17, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

inulin senstivity, testosterone, aerobic exercise

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)

EXPERIMENTAL

20 patients performed a programme of aerobic exercise 3-5 days/ week

Other: aerobic exercise

added sugar elimination (group II)

EXPERIMENTAL

20 patients performed a programme of added sugar elimination

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

Combination Product: 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

Aerobic exercise (group I)

specialized programme of eliminating all kinds of added sugar (all kinds of sugars that are not naturally occurring in natural foods

added sugar elimination (group II)

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

Aerobic exercise and added sugar elimination (group III)

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • zainab saeed aly, lecturer at Horus university

    cairo universiyu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zainab saeed aly, lecturer at Horus university

CONTACT

hanaa mohamed elzoghby, lecturer at Horus university

CONTACT

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