NCT05895435

Brief Summary

  • Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)
  • The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 31, 2023

Last Update Submit

May 31, 2023

Conditions

Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis

    measure before and after tratement programm

    8 week

Secondary Outcomes (3)

  • waist circumferance using tape measurment

    8 week

  • body mass index

    8 week

  • weight

    8 week

Study Arms (2)

first group

EXPERIMENTAL

Group (A) (Control Group): It will be consisted of 30 patients who will receive aerobic exercise and diet for 8 successive weeks 2 sessions per week.

Other: aerobic exercise

second group

EXPERIMENTAL

Group (B) (Study Group): It will be consisted of 30 patients who will receive aerobic exercise and diet and radiofrequency for 8 successive weeks 2 sessions per week.

Device: radiofrequancyOther: aerobic exercise

Interventions

radiofrequancyDEVICE

* Power of device: 150 W * Duration of the session: 40 minutes * Frequency: 2 sessions per week for 8 week. * Heating temperature: According to patient tolerance.

second group
aerobic exerciseOTHER

The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination

first groupsecond group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages will be ranged from 45 to 60 years 2- BMI \> 25 kg/m² and \< 35 kg/m². 3- Waist circumference more than 88cm

You may not qualify if:

  • Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health care-seeking for menopausal problems. Climacteric. 2003 Jun;6(2):112-7.

    PMID: 12841881BACKGROUND

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

mahmoud adel darahem

CONTACT

01028911100mahmouddarahem2023@gamil.com

afaf mohamed botla

CONTACT

01283126608drafafmohamed@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
effect of radiofrequancy on postmenopausal adipose tissue

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

May 31, 2023

Primary Completion

October 15, 2023

Study Completion

October 18, 2023

Last Updated

June 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access