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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06377657
• Other study ID #: DONT4GET
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: February 19, 2024

Study information

• Verified date: April 2024
• Source: University of Nis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 19, 2024
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran	Amol

Sponsors (1)

Lead Sponsor	Collaborator
University of Nis

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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