Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

NCT ID: NCT05818293

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-09

Study Completion Date

2023-11-10

Brief Summary

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insulin resistance as the prime factor linking visceral obesity with adverse metabolic changes. Analysis of abdominal obesity by imaging studies have generally reached the conclusion that it is the excess of intra-abdominal or visceral adipose tissue .Multiple environmental and genetic factors are thought to influence the manifestation of abdominal obesity. The expanded adipose tissue contributes to expose the liver to high concentrations of free fatty acids (FFA), impairing several hepatic metabolic processes leading to hyperinsulinemia .On the other side, there is an increase in the secretion of different adipokines, such as interleukin IL-6 and tumor necrosis factor-α (TNF-α), which also contributes to the insulin-resistant state .

So, RF technology deployed by Vanquish uses oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. Since fat biophysical characteristics behave like an insulator capable of polarization, it absorbs the high RF-related heat release from the RF applicator driving specific fat necrosis and consequent lipolysis. Patients lay underneath the device while the focused-field radiofrequency heats up the underlying .

Detailed Description

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The eligible participants will be divided into two equal groups included fifty two post-menopausal women. They will be selected randomly from El kalil Ebrahem hospital in Hadaek El Maadi.

Each group will be twenty six women. Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits. This group will receive 30 minutes on the abdominal area by radiofrequency, twice per week. The treatment procedure consists of placing the emitting panel over abdomen and flanks close to the skin using a spacer which standardizes distance between the panel and the body surface.

Once it is in supine position, with a pillow under their heads and with their knees in flexion. Initially, the abdominal region of each participant was divided into two equal parts- right and left-with the line Alba as reference.

Group (B) (control group) will receive regular diet habits only.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1\) Radiofrequency (RF):

* Twenty six post-menopausal women in group (A) will receive RF, is a healthy and effective method for reducing the abdominal obesity regulation of insulin secretion, and enhance quality of life of post-menopausal women. It will be directed to group (A) only .
* Group (A) will receive 30 minutes on the abdominal area, twice per week, as recommended in the standard treatment protocol by the manufacturer. Group (B) (control group) will receive regular diet habits only.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

will be blind

Study Groups

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study group -control group

Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits.

Group Type EXPERIMENTAL

radiofrquency device

Intervention Type DEVICE

• The radiofrequency system has been used for treatment of subcutaneous fat layers.

control group

Group (B) (control group) will receive regular diet habits only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiofrquency device

• The radiofrequency system has been used for treatment of subcutaneous fat layers.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • All participants post-menopausal from at least 3 years.

* All participants' ages will be ranged from 48-60 years old.
* All participants BMI will exceed 30 kg/m2.
* All participants waist hip ratio will be equal or more than 0, 89.

Exclusion Criteria

* • Surgical liposuction within the last 12 months.

* Untreated hypo- or hyperthyroidism.
* Uncontrolled liver, kidney or cardiovascular disease or diabetes.
* Implanted pacemaker or metal implant.
* History of thrombophlebitis, any hematological disease.
* No past or present neurological and musculoskeletal disorders that will have affected health condition.
* No smoking and drinking habits.
* No psychological problems.
Minimum Eligible Age

48 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shymaa Mohammed Abdo Mohammed

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shymaa M. Mohammed, MSC

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Hadiek El Maadi center

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shymaa M Mohammed, MSc

Role: CONTACT

+201096777275

Dalia D Awad, PHD

Role: CONTACT

01273990045

Facility Contacts

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Shymaa M. Mohammed

Role: primary

+201096777275

Dalia D. Awad, PHD

Role: backup

+2012273990045

Other Identifiers

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012/003806

Identifier Type: -

Identifier Source: org_study_id

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