radiofrequency: Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05818293

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Device: radiofrquency device	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

will be blind

Primary Purpose:

Treatment

Official Title:

Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group -control group Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits.	Device: radiofrquency device • The radiofrequency system has been used for treatment of subcutaneous fat layers.
No Intervention: control group Group (B) (control group) will receive regular diet habits only.

Arm

Intervention/Treatment

Experimental: study group -control group

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

Device: radiofrquency device

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

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN effect of radiofrequency on insulin resistance in obese post menopausal women [4 months]
RF will use to reduce subcutaneous fat in abdomen and buttocks. he outcome measures to assess the insulin resistance by Homeostasis Model Assessment (HOMA), abdominal obesity by abdominal ultrasound and waist \hip ratio. The Homeostasis Model Assessment (HOMA) : Is a model of interactions between glucose and insulin dynamics that is then used to predict fasting steady-state glucose and insulin concentrations for a wide range of possible combinations of insulin resistance and β-cell function. The model assumes a feedback loop between the liver and β-cell . Abdominal Ultrasound: To assess abdominal fat for all participants before and after treatment program.

Eligibility Criteria

Criteria

Ages Eligible for Study:

48 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shymaa Mohammed Abdo Mohammed, physiotherapist, Cairo University

ClinicalTrials.gov Identifier:

NCT05818293

Other Study ID Numbers:

012/003806

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Apr 18, 2023