Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

Obesity, Abdominal Clinical Trial

Official title:

Effect of Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile in Obese Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290674
• Other study ID #: P.T.REC/012/004043
• Status: Completed
• Phase: N/A
• Start date: September 11, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women.

Description:

Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and androcidal fat redistribution. Abdominal adiposity, defined as a waist circumference ≥88cm in women, measured in the upright position, plus significant elevated lipid profile values. In postmenopausal women, a higher level of physical activity was associated with a more optimal body composition, including lower adiposity and higher lean mass. Management of abdominal obesity involves different techniques i.e., dietary management, exercise therapy, even lifestyle management, and pharmacological management, and surgical interventions. Extracorporeal shockwave provides cavitation phenomena that may facilitate better management of abdominal obesity. Thus, current study will be conducted to investigate effect of extracorporeal shockwave on abdominal adiposity and lipid profile in obese post-menopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Their age range 45-60 years old.

• Their body mass index range 30-35 kg/m square.

• Only, obese postmenopausal women with at least one year after stoppage of menses.

Exclusion Criteria:

• Receiving pharmacological treatment.

• Receiving any form of electrotherapy.

• Whom with metabolic, hematological or renal dysfunction.

• Whom have dermatological or cardiovascular or respiratory, digestive or rheumatic disorders.

Related Conditions & MeSH terms

• Obesity, Abdominal

Intervention

Other:
• Extracorporeal Shockwave therapy
2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.
• Balanced low-calorie diet
1500 k/cal for 6 weeks

Locations

Country	Name	City	State
Egypt	Helwan General Hospital	Cairo	Helwan, Cairo Governate

Sponsors (1)

Lead Sponsor	Collaborator
Adly A Adam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist/ hip ratio	anthropometric outcome measure for abdominal adiposity	Pretreatment and Posttreatment of six weeks study protocol.
Primary	Skin fold caliper	subcutaneous fat outcome measure	Pretreatment and Posttreatment of six weeks study protocol.
Secondary	Lipid profile	Low-density lipoprotein, High-density lipoprotein, and triglyceride laboratory outcome measures.	Pretreatment and Posttreatment of six weeks study protocol.