Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM

METRNL Response, Plasma Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With Diabetes Type 2

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Behavioral: Exercise; Dietary supplement: Aloe vera

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Amol, Iran, Islamic Republic of
    • Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Intensity Interval Training; Participants in HIIT group underwent 3 sessions per week for 12 weeks. The HIIT protocol (maximum 60 cycles per 20-minute session) includes 8-second fast pedaling (approximately 80% of maximum heart rate (HR max)) followed by slow pedaling (20-30 rpm) for 12 seconds. To facilitate acceleration and limit the stagnation of the bicycle wheel, the selected resistance was very low (almost zero).	Behavioral: Exercise; The HIIT group underwent intervention with high intensity interval training. The second group was treated only with aloe vera supplementation for 12 weeks. A third group underwent a combination of HIIT and supplementation, while a fourth - CON group kept usual activities during the intervention duratino
Experimental: Aloe Vera supplementation; Participants in Aloe Vera group underwent supplementation with Aloe vera capsule containing 100 mg of Aloe vera gel powder in the morning immediately after waking up and one capsule after dinner.	Dietary supplement: Aloe vera; Aloe Vera group was treated only with aloe vera supplementation for 12 weeks.
Experimental: HIIT + Aloe Vera; Participants in HIIT group underwent 3 sessions per week for 12 weeks. The HIIT protocol (maximum 60 cycles per 20-minute session) includes 8-second fast pedaling (approximately 80% of maximum heart rate (HR max)) followed by slow pedaling (20-30 rpm) for 12 seconds. To facilitate acceleration and limit the stagnation of the bicycle wheel, the selected resistance was very low (almost zero). Additionally, patients underwent supplementation with Aloe Vera capsules in the morning and after the dinner.	Behavioral: Exercise; The HIIT group underwent intervention with high intensity interval training. The second group was treated only with aloe vera supplementation for 12 weeks. A third group underwent a combination of HIIT and supplementation, while a fourth - CON group kept usual activities during the intervention duratino; Dietary supplement: Aloe vera; Aloe Vera group was treated only with aloe vera supplementation for 12 weeks.
No Intervention: Control group; The control group continued their daily life activities for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
METRNL - Meteorin Like, Glial Cell Differentiation Regulator	Plasma METRNL content was measured using a special kit (Mybiosource company, USA) with a sensitivity of <0.64 ng / ml, range of 1.56-100 ng / ml by ELISA method	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glutathione peroxidase (GPx)	GPx was measured using a special kit (abcam company, USA) through ELISA method.	Baseline and 12 weeks
Serum superoxide dismutase (SOD)	SOD was measured using a special kit (Abcam company, USA) through ELISA method.	Baseline and and 12 weeks
Total antioxidant blood capacity (TAD)	TAD was measured using a special kit (Abcam company, USA) through ELISA method.	Baseline and 12 weeks
Plasma malondialdehyde (MDA)	MDA was measured using a special kit (Abcam company, USA) through ELISA method.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Nis
• Investigators: Principal Investigator: Anja Lazić, Prof., Faculty of Sport and Physical Education, University of Niš

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): February 19, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: exercise, blood glucose oxidative stress, diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DONT4GET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No