Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

NCT05818293 | Unknown DMC

• 1 other identifier: 012/003806
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 .

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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. 1. 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 . 2. Abdominal Ultrasound: To assess abdominal fat for all participants before and after treatment program.

  4 months

Study Arms (2)

study group -control group

EXPERIMENTAL

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

Device: radiofrquency device

control group

NO INTERVENTION

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

Interventions

radiofrquency device DEVICE

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

study group -control group

Eligibility Criteria

• Age: 48 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hadiek El Maadi center

Cairo, 19899, Egypt

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shymaa M. Mohammed, MSC

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shymaa M Mohammed, MSc

CONTACT

+201096777275; shymaamohammed269@gmail.com

Dalia D Awad, PHD

CONTACT

01273990045; Dalia82@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: April 18, 2023
• Study Start: July 9, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)