Clinical trial NCT06654908: Insulin Resistance and Resisted Exercise Post Burn
Official title: Insulin Resistance and Resisted Exercise Post Burn
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* - 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

Primary outcomes:
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.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Amany Rt Abdel Wahid, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Angelidi AM, Filippaios A, Mantzoros CS. Severe insulin resistance syndromes. J Clin Invest. 2021 Feb 15;131(4):e142245. doi: 10.1172/JCI142245.
citation: Wallace 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.
citation: Hardee 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.
citation: Lippi 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.