Diabete Type 2NCT06450847
Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.
A study testing Soleus Muscle Push Up Exercise and Other Exercise in people with Diabete Type 2 and Obesity, run by University of Sharjah.
Trial summary
The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Obesity, Overweight
- What is being tested?
- Soleus Muscle Push Up Exercise and Other Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Oct 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Residents of UAE, both males and females
- Ages 20-50 years
- Uncomplicated Type 2 Diabetic on meds,
- Normal lean BMI
- Overweight and Obese
Who cannot join
- Recent orthopedic surgery in the LLs
- Pain in the LLs starting from Hips to Ankle.
- Presence of Varicose Veins in the LLs
- Present History of any cardiovascular condition
- Pregnant females
- Morbid Obesity
- Diabetics undergoing Insulin therapy only
- Smokers and alcohol consumption
Trial locations and contacts
No sites are listed yet.
About this study
The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.
- Conditions
- Diabete Type 2, Obesity, Overweight
- Being tested
- Soleus Muscle Push Up Exercise, Other Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soleus Muscle Push Up ExerciseOther
Members will be asked to do the SPUs for 270 minutes/day for most days of the week (minimum 5 days) for 3 months:
- Begin seated on a bench or chair so knees form a 90-degree angle with feet flat on the floor and toes pointed forward. Keep spine straight and shoulders back (not hunched or rounded forward).
- Using a slow and controlled tempo, push toes into the floor and lift heels off the ground.
- Hold for one to two seconds, pushing down on the balls of feet. Keep your thigh muscles relaxed.
- Slowly lower heels and return to start. That's 1 rep. Without shoes Educational session will be given before the intervention time WhatsApp messages will be sent 1-2 times/day to remind the participants to continue doing the exercise and ascertain compliance. Also, the participants are required to daily fill logbook about the duration (in minutes) of the SPU that they did.
Other ExerciseOther
Participants will be asked to continue their regular lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Active comparator | Not described Receives: Other: Soleus Muscle Push Up Exercise |
| Control group | Placebo comparator | Not described Receives: Other: Other Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipocytokine levels in the blood
Measured in μg/ml, using blood test by specialized personnel
Measured: 3 months
Secondary outcomes (1)
Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample.
Measured as a number, in repetitions. Detailed procedure described previously.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amenah Hisham Abdelazim, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450847
- Sponsor's protocol ID
- USharjah1
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In case of the need for further expansion of the research, the information might be shared with other researchers in the university without exposure of any personal information or names of participants.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.
- ClinicalTrials.gov ID
- NCT06450847
- Acronym / sponsor ID
- USharjah1
- Conditions
- Diabete Type 2, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Jun 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.
The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Active comparator | Other: Soleus Muscle Push Up Exercise |
| Control group | Placebo comparator | Other: Other Exercise |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Residents of UAE, both males and females
- Ages 20-50 years
- Uncomplicated Type 2 Diabetic on meds,
- Normal lean BMI
- Overweight and Obese
Key exclusion criteria (8 listed)
- Recent orthopedic surgery in the LLs
- Pain in the LLs starting from Hips to Ankle.
- Presence of Varicose Veins in the LLs
- Present History of any cardiovascular condition
- Pregnant females
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 |
|---|---|---|
| Soleus Muscle Push Up ExerciseMembers will be asked to do the SPUs for 270 minutes/day for most days of the week (minimum 5 days) for 3 months: 1. Begin seated on a bench or chair so knees form a 90-degree angle with feet flat on the floor and toes pointed forward. Keep spine straight and shoulders back (not hunched or rounded forward). 2. Using a slow and controlled tempo, push toes into the floor and lift heels off the ground. 3. Hold for one to two seconds, pushing down on the balls of feet. Keep your thigh muscles relaxed. 4. Slowly lower heels and return to start. That's 1 rep. Without shoes Educational session will be given before the intervention time WhatsApp messages will be sent 1-2 times/day to remind the participants to continue doing the exercise and ascertain compliance. Also, the participants are required to daily fill logbook about the duration (in minutes) of the SPU that they did. | Other | Interventional group |
| Other ExerciseParticipants will be asked to continue their regular lifestyle | Other | Control group |
Primary outcome
Adipocytokine levels in the blood
Time frame: 3 months
Measured in μg/ml, using blood test by specialized personnel
1 secondary outcome
Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: Yes. In case of the need for further expansion of the research, the information might be shared with other researchers in the university without exposure of any personal information or names of participants.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Soleus Muscle Push Up Exercise and Other Exercise in people with Diabete Type 2 and Obesity, run by University of Sharjah.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amenah Abdelazim, BPT (+971554590707, aabdelazim@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipocytokine levels in the blood (time frame: 3 months). 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 10 Jun 2024.