Diabetes Type 2NCT06377657
Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM
A study testing Exercise and Aloe vera in people with Diabetes Type 2, run by University of Nis at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men only
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Exercise and Aloe vera
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIran
- Study dates
- 15 Jan 2022to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran
Āmol
About this study
Official title: 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.
Read more
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
- Being tested
- Exercise, Aloe vera
- Keywords
- exercise, blood glucose oxidative stress, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 veraDietary supplement
Aloe Vera group was treated only with aloe vera supplementation for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Behavioral: Exercise; Dietary Supplement: Aloe vera |
| Control group | No intervention | The control group continued their daily life activities for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Glutathione peroxidase (GPx)
GPx was measured using a special kit (abcam company, USA) through ELISA method.
Measured: Baseline and 12 weeks
Serum superoxide dismutase (SOD)
SOD was measured using a special kit (Abcam company, USA) through ELISA method.
Measured: Baseline and and 12 weeks
Total antioxidant blood capacity (TAD)
TAD was measured using a special kit (Abcam company, USA) through ELISA method.
Measured: Baseline and 12 weeks
Plasma malondialdehyde (MDA)
MDA was measured using a special kit (Abcam company, USA) through ELISA method.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Jan 2022
- Primary completion21 Jun 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Lazić, University of Nis
- Investigators
- Anja Lazić, Prof., Principal investigator, Faculty of Sport and Physical Education, University of Niš
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377657
- Sponsor's protocol ID
- DONT4GET
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METRNL Response, Plasma Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With Diabetes Type 2
- ClinicalTrials.gov ID
- NCT06377657
- Acronym / sponsor ID
- DONT4GET
- Conditions
- Diabetes Type 2
- Keywords
- exercise, blood glucose oxidative stress, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of NisUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: ExerciseParticipants 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). |
| Aloe Vera supplementation | Experimental | Dietary Supplement: Aloe veraParticipants 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. |
| HIIT + Aloe Vera | Experimental | Behavioral: Exercise, Dietary Supplement: Aloe veraParticipants 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. |
| Control group | No intervention | –The control group continued their daily life activities for 12 weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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 | Behavioural | HIIT + Aloe Vera, High-Intensity Interval Training |
| Aloe veraAloe Vera group was treated only with aloe vera supplementation for 12 weeks. | Dietary supplement | Aloe Vera supplementation, HIIT + Aloe Vera |
Primary outcome
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
4 secondary outcomes
Glutathione peroxidase (GPx)
Time frame: Baseline and 12 weeks
Serum superoxide dismutase (SOD)
Time frame: Baseline and and 12 weeks
Total antioxidant blood capacity (TAD)
Time frame: Baseline and 12 weeks
Plasma malondialdehyde (MDA)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Lazić, Prof. principal investigator
Faculty of Sport and Physical Education, University of Niš
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Aloe vera in people with Diabetes Type 2, run by University of Nis at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
METRNL - Meteorin Like, Glial Cell Differentiation Regulator (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.