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Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Primary Purpose

Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radiofrquency device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

48 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hadiek El Maadi centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study group -control group

control group

Arm Description

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

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

Outcomes

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2023
Last Updated
July 10, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05818293
Brief Title
Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women
Official Title
Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
will be blind
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group -control group
Arm Type
Experimental
Arm Description
Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Group (B) (control group) will receive regular diet habits only.
Intervention Type
Device
Intervention Name(s)
radiofrquency device
Intervention Description
• The radiofrequency system has been used for treatment of subcutaneous fat layers.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shymaa M Mohammed, MSc
Phone
+201096777275
Email
shymaamohammed269@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia D Awad, PHD
Phone
01273990045
Email
Dalia82@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shymaa M. Mohammed, MSC
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadiek El Maadi center
City
Cairo
ZIP/Postal Code
19899
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shymaa M. Mohammed
Phone
+201096777275
Email
shymaamohammed269@gmail.com
First Name & Middle Initial & Last Name & Degree
Dalia D. Awad, PHD
Phone
+2012273990045
Email
dalia82@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

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