NCT06667648

Brief 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 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2014

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

10.5 years

First QC Date

October 16, 2024

Last Update Submit

February 5, 2025

Conditions

Keywords

diabetes, cupping, aerobic excercise

Outcome Measures

Primary Outcomes (3)

  • interleukin 6 concentrations

    Kits for blood sample to detect serum interleukin 6

    6 months

  • blood sugar level mg/dl

    blood sample to determine blood sugar level

    6 months

  • tumor necrosis factor percent

    kits to determine tumor necrosis factor alpha

    6 months

Study Arms (2)

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.

Procedure: cupping session

Interventions

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.

Group (B)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • had diabetes more than 10 years ago
  • body mass index of 25 to 29.9 Kg/m2

You may not qualify if:

  • Hepatic diseases, Cancer patients, Renal failure patients, Orthopedic problems or fractures of extremities, hypertensive patients, and Neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of pharmaceutics and clinical pharmacy

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 31, 2024

Study Start

March 15, 2014

Primary Completion

September 11, 2024

Study Completion

October 15, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02