Insulin ResistanceNCT06654908
Insulin Resistance and Resisted Exercise Post Burn
A study testing resisted exercise using sand bags,resistance machines and elastic bands in people with Insulin Resistance, run by Cairo University.
Trial summary
The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- resisted exercise using sand bags,resistance machines and elastic bands
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to Nov 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients ranged from 18-35 years of age.
- Patients has waist hip ratio around 0.8 in female and 0.95 in male.
- Patient has body mass index (BMI around 25 kg/m2) (J Obes Weight Loss Ther ,2015).
- Patients has second degree thermal burn injury (superficial and deep partial thickness).
- Patients with around (20% - 40%) of total body surface area (TBSA) burned.
- Patients who are able to follow verbal commands.
Show all 10Show fewer
- Patients will have upper limb and trunk burn.
- Patients with normal hemoglobin A1C (5.6 %).
- Patients should take diet rich protein, omega 3 and should have good sleep.
- Patients passed two months post severe burns
Who cannot join
- - Potential participants were excluded if they reported a leg amputation, anoxic brain injury, psychological disorders, quadriplegia, or severe behavior or cognitive disorders history of heart disease, stroke, diabetes mellitus, or any condition that would prevent them from engaging in an exercise study.
- Patients with liver disease, pancreatic disease or any disease affects metabolism.
- If they were already engaging in 2 or more planned exercise sessions per week.
- Patients with any medication to lower glucose levels. Blood pressure and medications to lower lipid levels
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.
Read the detailed description
A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences. Severe burn injuries, encompassing 20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic deregulation. Indeed, an extensive inflammatory response develops immediately following a severe burn to promote wound healing. This period, known as the "ebb" phase, is comparable with a fight-or-flight response and lasts for the first 72-96 h post injury .
Moreover, burn-induced muscle catabolism places a significant burden on the recovery process, as a 10%-30% loss impairs immune responses and delays wound healing, thereby increasing the risk of infection, and a 40% loss becomes fatal. Despite a mountainous effort to prevent muscle catabolism and wasting. Therefore, a better understanding of the pathophysiology and consequences of burn-induced skeletal muscle wasting is pivotal to alleviating hyper metabolism and reducing morbidity and mortality patients with severe burns .
Hence, extensive burn injury produce clinical syndromes characterized in part by "insulin resistance, it is unclear if these insulin resistant states are identical. To test if the maximal biological effectiveness of insulin is altered in burned patients
- Conditions
- Insulin Resistance
- Being tested
- resisted exercise using sand bags,resistance machines and elastic bands
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resisted exercise using sand bags,resistance machines and elastic bandsProcedure or surgery
Rehabilitative exercise training will be performed as previously described. All exercises will be performed using free weights, elastic bands and variable-resistance machines. Modifications to exercises will be made when appropriate depending on the patient injury characteristics. The load will be gradually increased from 50-60% of 3RM at the beginning of the program up to 80-85% of 3RM (repetitions maximum) at the end of the program. All exercise sessions will be preceded by a 5-minute warm-up at \<50% VO2peak. No strength training activities will be permitted outside the supervised training session; however, both groups will be encouraged to maintain normal daily activities
| Study group | Role | What they receive |
|---|---|---|
| Group A: (Study group) who have insulin resistance and who will receive resisted exercise | Experimental | This group includes 34 patients who have insulin resistance and who will receive resisted exercise Receives: Procedure: resisted exercise using sand bags,resistance machines and elastic bands |
| Group B: (Control group) who have insulin resistance and who will receive routine medical treatment. | No intervention | This group includes 34 patients who have insulin resistance and who will receive routine medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the outcome of resisted exercises on the improvement of HOMA-IR test results for patients who have around (20% - 40%) of total body surface area (TBSA) burned.
sixty-eight patients, who have upper limb and trunk burn. Their ages will be ranged from 18-35 year old. Only patients around (20% - 40%) of total body surface area (TBSA) burned. The participants will be selected from government hospitals (General and insurance hospitals) and randomly distributed into 2 equal groups (group A, group B).
HOMA-IR analysis measurements:
All measurements will be taken before the treatment program, 6 weeks after the beginning of treatment program and 12 weeks after the beginning of the treatment program.
Assessment of insulin resistance:
- By doing HOMA-IR analysis. HOMA-IR test was performed for both groups before the treatment program, after the 6 weeks of the treatment program and after 12 weeks of the treatment program to evaluate the progression of insulin resistance in both groups.
The HOMA score of <1.9 was considered as indicator of "Insulin sensitivity"; 1.9 to 2.9 as indicator of "Low IR" and >2.9 as indicator of Significant IR
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Insulin 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saeed Abd El Aziz Gobara, Cairo University
- Investigators
- Amany Rt Abdel Wahid, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654908
- Sponsor's protocol ID
- insulin and resisted exercise
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levy-Marchal C, Arslanian S, Cutfield W, Sinaiko A, Druet C, Marcovecchio ML, Chiarelli F; ESPE-LWPES-ISPAD-APPES-APEG-SLEP-JSPE; Insulin Resistance in Children Consensus Conference Group. Insulin resistance in children: consensus, perspective, and future directions. J Clin Endocrinol Metab. 2010 Dec;95(12):5189-98. doi: 10.1210/jc.2010-1047. Epub 2010 Sep 8.
PubMed 20829185Angelidi AM, Filippaios A, Mantzoros CS. Severe insulin resistance syndromes. J Clin Invest. 2021 Feb 15;131(4):e142245. doi: 10.1172/JCI142245.
PubMed 33586681Wallace TM, Matthews DR. The assessment of insulin resistance in man. Diabet Med. 2002 Jul;19(7):527-34. doi: 10.1046/j.1464-5491.2002.00745.x.
PubMed 12099954Hardee JP, Porter C, Sidossis LS, Borsheim E, Carson JA, Herndon DN, Suman OE. Early rehabilitative exercise training in the recovery from pediatric burn. Med Sci Sports Exerc. 2014 Sep;46(9):1710-6. doi: 10.1249/MSS.0000000000000296.
PubMed 24824900Lippi G, Ippolito L, Cervellin G. Disseminated intravascular coagulation in burn injury. Semin Thromb Hemost. 2010 Jun;36(4):429-36. doi: 10.1055/s-0030-1254051. Epub 2010 Jul 7.
PubMed 20614394
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Resisted Exercise Post Burn
- ClinicalTrials.gov ID
- NCT06654908
- Acronym / sponsor ID
- insulin and resisted exercise
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 23 Oct 2024 (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 main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.
Detailed description
A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences. Severe burn injuries, encompassing 20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic deregulation. Indeed, an extensive inflammatory response develops immediately following a severe burn to promote wound healing. This period, known as the "ebb" phase, is comparable with a fight-or-flight response and lasts for the first 72-96 h post injury .
Moreover, burn-induced muscle catabolism places a significant burden on the recovery process, as a 10%-30% loss impairs immune responses and delays wound healing, thereby increasing the risk of infection, and a 40% loss becomes fatal. Despite a mountainous effort to prevent muscle catabolism and wasting. Therefore, a better understanding of the pathophysiology and consequences of burn-induced skeletal muscle wasting is pivotal to alleviating hyper metabolism and reducing morbidity and mortality patients with severe burns .
Hence, extensive burn injury produce clinical syndromes characterized in part by "insulin resistance, it is unclear if these insulin resistant states are identical. To test if the maximal biological effectiveness of insulin is altered in burned patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: (Study group) who have insulin resistance and who will receive resisted exercise | Experimental | Procedure: resisted exercise using sand bags,resistance machines and elastic bandsThis group includes 34 patients who have insulin resistance and who will receive resisted exercise |
| Group B: (Control group) who have insulin resistance and who will receive routine medical treatment. | No intervention | –This group includes 34 patients who have insulin resistance and who will receive routine medical treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients ranged from 18-35 years of age.
- Patients has waist hip ratio around 0.8 in female and 0.95 in male.
- Patient has body mass index (BMI around 25 kg/m2) (J Obes Weight Loss Ther ,2015).
- Patients has second degree thermal burn injury (superficial and deep partial thickness).
- Patients with around (20% - 40%) of total body surface area (TBSA) burned.
Key exclusion criteria (4 listed)
- - Potential participants were excluded if they reported a leg amputation, anoxic brain injury, psychological disorders, quadriplegia, or severe behavior or cognitive disorders history of heart disease, stroke, diabetes mellitus, or any condition that would prevent them from engaging in an exercise study.
- Patients with liver disease, pancreatic disease or any disease affects metabolism.
- If they were already engaging in 2 or more planned exercise sessions per week.
- Patients with any medication to lower glucose levels. Blood pressure and medications to lower lipid levels
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 |
|---|---|---|
| resisted exercise using sand bags,resistance machines and elastic bandsRehabilitative exercise training will be performed as previously described. All exercises will be performed using free weights, elastic bands and variable-resistance machines. Modifications to exercises will be made when appropriate depending on the patient injury characteristics. The load will be gradually increased from 50-60% of 3RM at the beginning of the program up to 80-85% of 3RM (repetitions maximum) at the end of the program. All exercise sessions will be preceded by a 5-minute warm-up at \<50% VO2peak. No strength training activities will be permitted outside the supervised training session; however, both groups will be encouraged to maintain normal daily activities | Procedure or surgery | Group A: (Study group) who have insulin resistance and who will receive resisted exercise |
Primary outcome
the outcome of resisted exercises on the improvement of HOMA-IR test results for patients who have around (20% - 40%) of total body surface area (TBSA) burned.
Time frame: baseline
sixty-eight patients, who have upper limb and trunk burn. Their ages will be ranged from 18-35 year old. Only patients around (20% - 40%) of total body surface area (TBSA) burned. The participants will be selected from government hospitals (General and insurance hospitals) and randomly distributed into 2 equal groups (group A, group B). HOMA-IR analysis measurements: All measurements will be taken before the treatment program, 6 weeks after the beginning of treatment program and 12 weeks after the beginning of the treatment program. Assessment of insulin resistance: • By doing HOMA-IR analysis. HOMA-IR test was performed for both groups before the treatment program, after the 6 weeks of the treatment program and after 12 weeks of the treatment program to evaluate the progression of insulin resistance in both groups. The HOMA score of <1.9 was considered as indicator of "Insulin sensitivity"; 1.9 to 2.9 as indicator of "Low IR" and >2.9 as indicator of Significant IR
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 23 Oct 2024.
- Background: PubMed 20829185Levy-Marchal C, Arslanian S, Cutfield W, Sinaiko A, Druet C, Marcovecchio ML, Chiarelli F; ESPE-LWPES-ISPAD-APPES-APEG-SLEP-JSPE; Insulin Resistance in Children Consensus Conference Group. Insulin resistance in children: consensus, perspective, and future directions. J Clin Endocrinol Metab. 2010 Dec;95(12):5189-98. doi: 10.1210/jc.2010-1047. Epub 2010 Sep 8.
- Background: PubMed 33586681Angelidi AM, Filippaios A, Mantzoros CS. Severe insulin resistance syndromes. J Clin Invest. 2021 Feb 15;131(4):e142245. doi: 10.1172/JCI142245.
- Background: PubMed 12099954Wallace TM, Matthews DR. The assessment of insulin resistance in man. Diabet Med. 2002 Jul;19(7):527-34. doi: 10.1046/j.1464-5491.2002.00745.x.
- Background: PubMed 24824900Hardee JP, Porter C, Sidossis LS, Borsheim E, Carson JA, Herndon DN, Suman OE. Early rehabilitative exercise training in the recovery from pediatric burn. Med Sci Sports Exerc. 2014 Sep;46(9):1710-6. doi: 10.1249/MSS.0000000000000296.
- Background: PubMed 20614394Lippi G, Ippolito L, Cervellin G. Disseminated intravascular coagulation in burn injury. Semin Thromb Hemost. 2010 Jun;36(4):429-36. doi: 10.1055/s-0030-1254051. Epub 2010 Jul 7.
- national library of medicine , national centre of biotechnology informationLink provided by the sponsor.
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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.
Amany Rt Abdel Wahid, lecturer principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing resisted exercise using sand bags,resistance machines and elastic bands in people with Insulin Resistance, 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?
The sponsor lists 10 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Oct 2024. 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 mahmoud Sd gobara, bachelor (800-555-5555, mahmoudgobara14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outcome of resisted exercises on the improvement of HOMA-IR test results for patients who have around (20% - 40%) of total body surface area (TBSA) burned. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654908, which also lists 5 linked publications.
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 23 Oct 2024.