DiabetesNCT06667648
Effect of Wet Cupping Versus Moderate Intensity Aerobic Exercise on Inflammatory Markers in Diabetic Patients
A study testing cupping session in people with Diabetes, run by Deraya University.
Trial summary
Among all pro-inflammatory biomarkers, TNF-α first recognized to be involved in the pathenogenesis of insulin resistance, and glucose-related abnormalities that link to T2DM. TNF-α plays a vital role in the overall pathophysiology of insulin resistance especially in males with greater body mass index as compared to… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Diabetes
- What is being tested?
- cupping session
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2014to 15 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- had diabetes more than 10 years ago
- body mass index of 25 to 29.9 Kg/m2
Who cannot join
- Hepatic diseases, Cancer patients, Renal failure patients, Orthopedic problems or fractures of extremities, hypertensive patients, and Neurological problems
About this study
Among all pro-inflammatory biomarkers, TNF-α first recognized to be involved in the pathenogenesis of insulin resistance, and glucose-related abnormalities that link to T2DM. TNF-α plays a vital role in the overall pathophysiology of insulin resistance especially in males with greater body mass index as compared to that in the females This trial aims to investigate the effect of wet cupping therapy versus moderate intensity aerobic exercise on inflammatory markers in diabetic patients
Read the detailed description
Cupping therapy is a traditional treatment used to create suction on the skin over a painful area or acupuncture point using a bamboo or glass cup. Aerobic exercise (also known as endurance activities, cardio, or cardio-respiratory exercise) is physical exercise of low to high intensity that depends primarily on the aerobic energy-generating process. Chronic inflammation, including elevated levels of interleukin 6 (IL-6), is associated with diabetes, cardiovascular disease, and chronic kidney disease, as well as related diseases such as nonalcoholic hepatosteatosis. Amongst other triggers, elevated IL-6 levels may arise due to excess adipose tissue and can cause, for example, aberrant glucose metabolism leading to diabetes and other manifestations of the ensuing glucotoxicity in many tissues and organs, including the vasculature and other parts of the heart and the kidneys, as well as in the liver. The purpose of this study was to investigate the effect of wet cupping therapy versus moderate-intensity aerobic exercise on inflammatory markers in diabetic patients.
- Conditions
- Diabetes
- Being tested
- cupping session
- Keywords
- diabetes, cupping, aerobic excercise
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cupping sessionProcedure or surgery
Each cupping session takes about 30-40 min and can be conducted in five steps. The first step includes primary suction. In this phase, the therapist allocates specific points or areas for cupping and disinfects the area, which located at the upper back (opposite to C7), Para spinal and below scapula. A cup with a suitable size is placed on the selected site and sucked the air inside the cup by manual suction. Then the cup was applied to the skin and left for a period of 3 to 5 min. The second step is about puncturing. Puncturing with a needle to get out of blood the third step is about suction and bloodletting. The cup is placed back on the skin using the similar procedure described above for 3 to 5 min. The fourth step includes the removal of the cup, followed by the fifth step which includes dressing the area after cleaning and disinfecting with FDA-approved skin disinfectant.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | No intervention | ) attended the program of walking on a treadmill machine for eight weeks according to the following parameters: - * Mode of exercise: aerobic exercise. * Intensity: according to heart rate (60-75% of maximum heart rate) MHR=220-age. * Heart rate: determined by the sensor of a treadmill. * Duration: 40-50 min per session. Each session consisted of 5-10 minutes of warming up exercise on a treadmill without increasing speed or intensity and the same for the cooling down phase |
| Group (B) | Other | Each cupping session takes about 30-40 min and can be conducted in five steps. The first step includes primary suction. In this phase, the therapist allocates specific points or areas for cupping and disinfects the area, which located at the upper back (opposite to C7), Para spinal and below scapula. A cup with a suitable size is placed on the selected site and sucked the air inside the cup by manual suction. Then the cup was applied to the skin and left for a period of 3 to 5 min. The second step is about puncturing. Puncturing with a needle to get out of blood the third step is about suction and bloodletting. The cup is placed back on the skin using the similar procedure described above for 3 to 5 min. The fourth step includes the removal of the cup, followed by the fifth step which includes dressing the area after cleaning and disinfecting with FDA-approved skin disinfectant. Receives: Procedure: cupping session |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 6 concentrations
Kits for blood sample to detect serum interleukin 6
Measured: 6 months
blood sugar level mg/dl
blood sample to determine blood sugar level
Measured: 6 months
tumor necrosis factor percent
kits to determine tumor necrosis factor alpha
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Mar 2014
- Primary completion11 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667648
- Sponsor's protocol ID
- Physical Therapy 2024
- Status last verified
- Feb 2025
- First submitted
- 16 Oct 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wet Cupping Versus Moderate Intensity Aerobic Exercise on Inflammatory Markers in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06667648
- Acronym / sponsor ID
- Physical Therapy 2024
- Conditions
- Diabetes
- Keywords
- diabetes, cupping, aerobic excercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 15 Mar 2014 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 31 Oct 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.
Among all pro-inflammatory biomarkers, TNF-α first recognized to be involved in the pathenogenesis of insulin resistance, and glucose-related abnormalities that link to T2DM. TNF-α plays a vital role in the overall pathophysiology of insulin resistance especially in males with greater body mass index as compared to that in the females This trial aims to investigate the effect of wet cupping therapy versus moderate intensity aerobic exercise on inflammatory markers in diabetic patients
Detailed description
Cupping therapy is a traditional treatment used to create suction on the skin over a painful area or acupuncture point using a bamboo or glass cup. Aerobic exercise (also known as endurance activities, cardio, or cardio-respiratory exercise) is physical exercise of low to high intensity that depends primarily on the aerobic energy-generating process. Chronic inflammation, including elevated levels of interleukin 6 (IL-6), is associated with diabetes, cardiovascular disease, and chronic kidney disease, as well as related diseases such as nonalcoholic hepatosteatosis. Amongst other triggers, elevated IL-6 levels may arise due to excess adipose tissue and can cause, for example, aberrant glucose metabolism leading to diabetes and other manifestations of the ensuing glucotoxicity in many tissues and organs, including the vasculature and other parts of the heart and the kidneys, as well as in the liver. The purpose of this study was to investigate the effect of wet cupping therapy versus moderate-intensity aerobic exercise on inflammatory markers in diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | No intervention | –) attended the program of walking on a treadmill machine for eight weeks according to the following parameters: - * Mode of exercise: aerobic exercise. * Intensity: according to heart rate (60-75% of maximum heart rate) MHR=220-age. * Heart rate: determined by the sensor of a treadmill. * Duration: 40-50 min per session. Each session consisted of 5-10 minutes of warming up exercise on a treadmill without increasing speed or intensity and the same for the cooling down phase |
| Group (B) | Other | Procedure: cupping sessionEach cupping session takes about 30-40 min and can be conducted in five steps. The first step includes primary suction. In this phase, the therapist allocates specific points or areas for cupping and disinfects the area, which located at the upper back (opposite to C7), Para spinal and below scapula. A cup with a suitable size is placed on the selected site and sucked the air inside the cup by manual suction. Then the cup was applied to the skin and left for a period of 3 to 5 min. The second step is about puncturing. Puncturing with a needle to get out of blood the third step is about suction and bloodletting. The cup is placed back on the skin using the similar procedure described above for 3 to 5 min. The fourth step includes the removal of the cup, followed by the fifth step which includes dressing the area after cleaning and disinfecting with FDA-approved skin disinfectant. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- had diabetes more than 10 years ago
- body mass index of 25 to 29.9 Kg/m2
Key exclusion criteria (1 listed)
- Hepatic diseases, Cancer patients, Renal failure patients, Orthopedic problems or fractures of extremities, hypertensive patients, and Neurological problems
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 |
|---|---|---|
| cupping sessionEach cupping session takes about 30-40 min and can be conducted in five steps. The first step includes primary suction. In this phase, the therapist allocates specific points or areas for cupping and disinfects the area, which located at the upper back (opposite to C7), Para spinal and below scapula. A cup with a suitable size is placed on the selected site and sucked the air inside the cup by manual suction. Then the cup was applied to the skin and left for a period of 3 to 5 min. The second step is about puncturing. Puncturing with a needle to get out of blood the third step is about suction and bloodletting. The cup is placed back on the skin using the similar procedure described above for 3 to 5 min. The fourth step includes the removal of the cup, followed by the fifth step which includes dressing the area after cleaning and disinfecting with FDA-approved skin disinfectant. | Procedure or surgery | Group (B) |
Primary outcome
interleukin 6 concentrations
Time frame: 6 months
Kits for blood sample to detect serum interleukin 6
blood sugar level mg/dl
Time frame: 6 months
blood sample to determine blood sugar level
tumor necrosis factor percent
Time frame: 6 months
kits to determine tumor necrosis factor alpha
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 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cupping session in people with Diabetes, run by Deraya University.
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 2 inclusion and 1 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 7 Feb 2025. 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. 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?
interleukin 6 concentrations (time frame: 6 months). The study lists 3 primary outcomes in all. 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 7 Feb 2025.