Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women

NCT07676279 | Completed

• 1 other identifier: 012/004731
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Serum interleukin-6

  Serum interleukin-6 (IL-6) levels were measured from venous blood samples using an enzyme-linked immunosorbent assay (ELISA). IL-6 concentrations were expressed in picograms per milliliter (pg/mL). The normal serum IL-6 level in healthy adults is generally less than 7 pg/mL, higher level indicates inflammatory conditions.

  12 weeks

• C- Reactive Proteins

  Serum C-reactive protein (CRP) levels were measured from venous blood samples using an immunoturbidimetric assay. CRP concentrations were expressed in milligrams per liter (mg/L). A CRP value below 5 mg/L is generally considered within the normal range. Higher levels indicate inflammatory diseases.

  12 weeks

Secondary Outcomes (9)

• Body weight

  12 weeks

• Body mass index

  12 weeks

• waist circumference

  12 weeks

• Hip circumference

  12 weeks

• waist-hip ratio

  12 weeks

Study Arms (2)

Cryolipolysis and aerobic exercise group

EXPERIMENTAL

The participants received cryolipolysis sessions on abdominal region (30 minutes/2 sessions per week for 12 weeks) in addition to moderate intensity Aerobic exercises on treadmill for 30 minutes/ 2sessions per week for 12 weeks.

Device: Cryolipolysis; Other: aerobic exercise

aerobic exercise group

ACTIVE COMPARATOR

The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks.

Other: aerobic exercise

Interventions

Cryolipolysis DEVICE

Vacuum controllable head with cold temperature range from -10 to 5°C technique was adjusted according to each patient tolerance, after careful patient sensation examination and vital signs evaluation before and after each session. Cryolipolysis sessions was applied at the hypogastrium area, 5 cm below the umbilicus, for 30 minutes with temperature degree of -5°C using an anti- freezing membrane to avoid cold burn. After starting the device on, the patient was instructed with safety measures to pull the key off if there was any intolerable abnormal sensation.

Cryolipolysis and aerobic exercise group

aerobic exercise OTHER

Participants received moderate intensity aerobic exercises 2 times/week for 12 weeks by using treadmill. Each session took about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill with low speed as in warming up (2 sessions/week)

Cryolipolysis and aerobic exercise group; aerobic exercise group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All participants were postmenopausal women.
• Their ages were ranged from 50 to 60 years old.
• Body mass index was ranged from 30-40 kg/m2.
• Waist to hip Ratio was between 0.8-1.0.

You may not qualify if:

• Systematic disease (uncontrolled hypertension, diabetes mellitus).
• Thyroid, liver and kidney dysfunctions.
• Psychiatric disorders.
• Women received any hormonal therapy or received corticosteroids in the last six months prior to the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Nada ElSayed Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Samira Swdky, Professor

  Al-Azhar University

  STUDY DIRECTOR

• Abeer ElDeeb, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: January 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 30, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

EG (1)