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NCT Number: NCT06377657

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

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.

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Key information

Conditions

Diabetes Type 2 Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

25 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Āmol, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Aloe Vera

Dietary Supplement

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

Primary outcomes

  1. METRNL - Meteorin Like, Glial Cell Differentiation Regulator

    Time frame: Baseline and 12 weeks

    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

Secondary outcomes

  1. Glutathione peroxidase (GPx)

    Time frame: Baseline and 12 weeks

    GPx was measured using a special kit (abcam company, USA) through ELISA method.

  2. Serum superoxide dismutase (SOD)

    Time frame: Baseline and and 12 weeks

    SOD was measured using a special kit (Abcam company, USA) through ELISA method.

  3. Total antioxidant blood capacity (TAD)

    Time frame: Baseline and 12 weeks

    TAD was measured using a special kit (Abcam company, USA) through ELISA method.

  4. Plasma malondialdehyde (MDA)

    Time frame: Baseline and 12 weeks

    MDA was measured using a special kit (Abcam company, USA) through ELISA method.

Sponsors and collaborators

Lead sponsor

University of Nis

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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