Clinical trial NCT06377657: Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM
Official title: METRNL Response, Plasma Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With Diabetes Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: exercise, blood glucose oxidative stress, diabetes mellitus
Lead sponsor: University of Nis
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 44
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.

Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.

Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.

The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity.


Eligibility criteria: Inclusion Criteria:

* Male participants who have been diagnosed with T2DM at least 3 months prior to the start of the study according to standard criteria
* Inactive participants according to the International Physical Activity Questionnaire (IPAQ)
* Participants receiving stable medical therapy for T2DM, excluding those on exogenous insulin therapy
* Participants who were free from injuries or chronic health conditions that could limit their ability to safely participate in an intense exercise program were included in the study

Exclusion Criteria:

* Fasting glucose above 270 mg / dL
* Exogenous insulin
* History of diabetic complications (the final stage of proliferative diabetic retinopathy, or subsequent overt nephropathy, diabetic ketoacidosis, or severe diabetic neuropathy)
* Hereditary glucose and galactose malabsorption

Primary outcomes:
measure: METRNL - Meteorin Like, Glial Cell Differentiation Regulator
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Glutathione peroxidase (GPx)
timeFrame: Baseline and 12 weeks
measure: Serum superoxide dismutase (SOD)
timeFrame: Baseline and and 12 weeks
measure: Total antioxidant blood capacity (TAD)
timeFrame: Baseline and 12 weeks
measure: Plasma malondialdehyde (MDA)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Amol
country: Iran, Islamic Republic of
facility: Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran
Study officials:
affiliation: Faculty of Sport and Physical Education, University of Niš
name: Anja Lazić, Prof.
role: PRINCIPAL_INVESTIGATOR
References: