Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Insulin Resistance Clinical Trial

Official title:

Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818293
• Other study ID #: 012/003806
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Shymaa M Mohammed, MSc
• Phone: +201096777275
• Email: shymaamohammed269[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Device:
• radiofrquency device
• The radiofrequency system has been used for treatment of subcutaneous fat layers.

Locations

Country	Name	City	State
Egypt	Hadiek El Maadi center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 ß-cell function. The model assumes a feedback loop between the liver and ß-cell .; Abdominal Ultrasound: To assess abdominal fat for all participants before and after treatment program.	4 months