- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667648
Effect of Wet Cupping Versus Moderate Intensity Aerobic Exercise on Inflammatory Markers in Diabetic Patients
February 5, 2025 updated by: Soad Ali, Deraya University
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- had diabetes more than 10 years ago
- body mass index of 25 to 29.9 Kg/m2
Exclusion Criteria:
- Hepatic diseases, Cancer patients, Renal failure patients, Orthopedic problems or fractures of extremities, hypertensive patients, and Neurological problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group (A)
) attended the program of walking on a treadmill machine for eight weeks according to the following parameters: -
|
|
|
Other: Group (B)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
interleukin 6 concentrations
Time Frame: 6 months
|
Kits for blood sample to detect serum interleukin 6
|
6 months
|
|
blood sugar level mg/dl
Time Frame: 6 months
|
blood sample to determine blood sugar level
|
6 months
|
|
tumor necrosis factor percent
Time Frame: 6 months
|
kits to determine tumor necrosis factor alpha
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2014
Primary Completion (Actual)
September 11, 2024
Study Completion (Actual)
October 15, 2024
Study Registration Dates
First Submitted
October 16, 2024
First Submitted That Met QC Criteria
October 30, 2024
First Posted (Actual)
October 31, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 5, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Physical Therapy 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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