Insulin Sensitivity/ResistanceNCT06772857
Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients
A study testing Metformin in people with Insulin Sensitivity/Resistance, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients. Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity/Resistance
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
- Body mass index (BMI) ranging from 30 to 34.9 kg/m².
- Insulin resistance as assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) levels above 1.9.
- Blood glucose levels ranging from 100 to 125 mg/dL (5.6-6.9 mmol/L).
- Patients will receive the same medical and diet regimen, with instructions not to change their physical activity during the study.
- HbA1c levels between 6.0% and 6.5%, indicating high risk for diabetes and possible consideration for prevention interventions.
Who cannot join
- Uncontrolled diabetes.
- Uncontrolled hypertension.
- Cardiovascular disease.
- Respiratory disease.
- Hepatic disease.
- Severe life-limiting illness (e.g., cancer).
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- Use of weight loss medications.
- Orthopedic or neurological disorders that limit exercise participation.
- Endocrine disorders.
- Kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients.
Read the detailed description
The global epidemic of obesity becomes a major healthy, social, and economical burden.Indeed, it has been well established that obesity directly increases cardio metabolic risk by altering the insulin sensibility. Moreover, obesity causes additional health problems as it is closely associated with the development and progression of coronary heart disease.
According to the World Health Organization (WHO), Egypt ranks 18th with the highest prevalence of obesity worldwide.( Global Obesity Levels,2020) Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden .(World Health Organization,2021) Lack of exercise and sedentary behaviour (prolonged sitting) are major risk factors for insulin resistance The prevalence of obesity has increased in adults in Egypt to reach about 40% according to 100million health survey (2019) compared to the 36% estimate of 2017 STEPwise survey .
This review presents established knowledge on the effects of physical activity (PA) on whole-body insulin sensitivity (SI) and body composition .
- Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
- Their body mass index will be ranged from 30 to 34.9 kg/m2.
- They have insulin resistance assessed by the homeostasis model assessment for insulin resistance (HOMAIR) Levels above 1.9
- Their blood glucose level will be ranged from 100 to 125 mg/dL (5.6-6.9 mmol/l)
- They will receive the same medical and diet regimen in addition to instructions not to change their physical activity during the study.
Study group A (20 patients):will receive aerobic exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.
Study group B (20 patients): will receive resistance exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.
Control group C (20 patients): will receive medical and diet regimen only for six weeks. The patients will be instructed not to change their physical activity during the study.
- Conditions
- Insulin Sensitivity/Resistance
- Being tested
- Metformin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Glucophage XR, Riomet
Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Aerobic Exercise + Medical and Diet Regimen | Experimental | Study group A (20 patients) will receive aerobic exercise training in addition to a medical and diet regimen. Aerobic exercise training will be applied 3 times per week for 6 weeks. This exercise will include activities such as walking, cycling, or swimming to improve cardiovascular fitness and insulin sensitivity. Receives: Drug: Metformin |
| Group B: Resistance Exercise + Medical and Diet Regimen | Experimental | Study group B (20 patients) will receive resistance exercise training along with a medical and diet regimen. Resistance exercise training will be applied 3 times per week for 6 weeks, focusing on strength-building exercises to improve muscle mass and insulin sensitivity. Receives: Drug: Metformin |
| Group C: Medical and Diet Regimen Only | Active comparator | Control group C (20 patients) will receive only a medical and diet regimen for 6 weeks. Patients in this group will be instructed not to change their physical activity during the study period. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Resistance Between Different Exercise Modes in Obese Patients
The change in insulin resistance will be assessed using the HOMA-IR index in obese patients after different exercise interventions (aerobic vs resistance) compared to baseline. The HOMA-IR index will be calculated based on fasting blood glucose and fasting insulin levels, which are widely accepted measures of insulin resistance.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start18 Jul 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Sensitivity/ResistanceStudies 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
- Model description
- The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Police Hospital
- Responsible party
- Principal investigator, El-Sayed Essam, Cairo University
- Investigators
- El-sayed Felaya, Principal investigator, Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772857
- Sponsor's protocol ID
- P.T.REC/012/004665
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients
- ClinicalTrials.gov ID
- NCT06772857
- Acronym / sponsor ID
- P.T.REC/012/004665
- Conditions
- Insulin Sensitivity/Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Police Hospital
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Jan 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 purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients.
Detailed description
The global epidemic of obesity becomes a major healthy, social, and economical burden.Indeed, it has been well established that obesity directly increases cardio metabolic risk by altering the insulin sensibility. Moreover, obesity causes additional health problems as it is closely associated with the development and progression of coronary heart disease.
According to the World Health Organization (WHO), Egypt ranks 18th with the highest prevalence of obesity worldwide.( Global Obesity Levels,2020) Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden .(World Health Organization,2021) Lack of exercise and sedentary behaviour (prolonged sitting) are major risk factors for insulin resistance The prevalence of obesity has increased in adults in Egypt to reach about 40% according to 100million health survey (2019) compared to the 36% estimate of 2017 STEPwise survey .
This review presents established knowledge on the effects of physical activity (PA) on whole-body insulin sensitivity (SI) and body composition .
- Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
- Their body mass index will be ranged from 30 to 34.9 kg/m2.
- They have insulin resistance assessed by the homeostasis model assessment for insulin resistance (HOMAIR) Levels above 1.9
- Their blood glucose level will be ranged from 100 to 125 mg/dL (5.6-6.9 mmol/l)
- They will receive the same medical and diet regimen in addition to instructions not to change their physical activity during the study.
Study group A (20 patients):will receive aerobic exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.
Study group B (20 patients): will receive resistance exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.
Control group C (20 patients): will receive medical and diet regimen only for six weeks. The patients will be instructed not to change their physical activity during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients
| Arm | Type | Receives |
|---|---|---|
| Group A: Aerobic Exercise + Medical and Diet Regimen | Experimental | Drug: MetforminStudy group A (20 patients) will receive aerobic exercise training in addition to a medical and diet regimen. Aerobic exercise training will be applied 3 times per week for 6 weeks. This exercise will include activities such as walking, cycling, or swimming to improve cardiovascular fitness and insulin sensitivity. |
| Group B: Resistance Exercise + Medical and Diet Regimen | Experimental | Drug: MetforminStudy group B (20 patients) will receive resistance exercise training along with a medical and diet regimen. Resistance exercise training will be applied 3 times per week for 6 weeks, focusing on strength-building exercises to improve muscle mass and insulin sensitivity. |
| Group C: Medical and Diet Regimen Only | Active comparator | Drug: MetforminControl group C (20 patients) will receive only a medical and diet regimen for 6 weeks. Patients in this group will be instructed not to change their physical activity during the study period. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
- Body mass index (BMI) ranging from 30 to 34.9 kg/m².
- Insulin resistance as assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) levels above 1.9.
- Blood glucose levels ranging from 100 to 125 mg/dL (5.6-6.9 mmol/L).
- Patients will receive the same medical and diet regimen, with instructions not to change their physical activity during the study.
Key exclusion criteria (10 listed)
- Uncontrolled diabetes.
- Uncontrolled hypertension.
- Cardiovascular disease.
- Respiratory disease.
- Hepatic disease.
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 |
|---|---|---|
| MetforminAlso: Glucophage, Glucophage XR, RiometMetformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study. | Drug | Group A: Aerobic Exercise + Medical and Diet Regimen, Group B: Resistance Exercise + Medical and Diet Regimen, Group C: Medical and Diet Regimen Only |
Primary outcome
Change in Insulin Resistance Between Different Exercise Modes in Obese Patients
Time frame: 3months
The change in insulin resistance will be assessed using the HOMA-IR index in obese patients after different exercise interventions (aerobic vs resistance) compared to baseline. The HOMA-IR index will be calculated based on fasting blood glucose and fasting insulin levels, which are widely accepted measures of insulin resistance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
El-sayed Felaya principal investigator
Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Insulin Sensitivity/Resistance, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Resistance Between Different Exercise Modes in Obese Patients (time frame: 3months). 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 22 Oct 2026.