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

NCT06377657 | Completed

• 1 other identifier: DONT4GET
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

exercise, blood glucose oxidative stress, diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Glutathione peroxidase (GPx)

  Baseline and 12 weeks

• Serum superoxide dismutase (SOD)

  Baseline and and 12 weeks

• Total antioxidant blood capacity (TAD)

  Baseline and 12 weeks

• Plasma malondialdehyde (MDA)

  Baseline and 12 weeks

Study Arms (4)

High-Intensity Interval Training

EXPERIMENTAL

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

Aloe Vera supplementation

EXPERIMENTAL

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

HIIT + Aloe Vera

EXPERIMENTAL

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; Dietary Supplement: Aloe vera

Control group

NO INTERVENTION

The control group continued their daily life activities for 12 weeks

Interventions

Exercise BEHAVIORAL

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

HIIT + Aloe Vera; High-Intensity Interval Training

Aloe vera DIETARY_SUPPLEMENT

Aloe Vera group was treated only with aloe vera supplementation for 12 weeks.

Aloe Vera supplementation; HIIT + Aloe Vera

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nis: lead

Study Sites (1)

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

Āmol, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anja Lazić, Prof.

  Faculty of Sport and Physical Education, University of Niš

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants were blinded for the supplementation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Researcher

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 22, 2024
• Study Start: January 15, 2022
• Primary Completion: June 21, 2023
• Study Completion: February 19, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

IR (1)