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CompletedNCT06290674Updated Jul 22, 2024

Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

An interventional study of Extracorporeal Shockwave therapy and Balanced low-calorie diet in Obesity, Abdominal, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2022, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Obesity, Abdominal

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03

In context

Obesity, Abdominal

274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Study Group (A) (ESWT)

    30 participants will receive Extracorporeal Shockwave (one session per week for 6 weeks), in addition to a balanced low-calorie diet (1500 k/cal for 6 weeks).

    Other: Extracorporeal Shockwave therapy · Other: Balanced low-calorie diet

  • Placebo comparator
    Control Group (B)

    30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only.

    Other: Balanced low-calorie diet

Interventions

  • OtherExtracorporeal Shockwave therapy

    2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.

  • OtherBalanced low-calorie diet

    1500 k/cal for 6 weeks

06

What researchers measure

Primary outcomes

  1. Waist/ hip ratio

    anthropometric outcome measure for abdominal adiposity

    Time frame: Pretreatment and Posttreatment of six weeks study protocol.

  2. Skin fold caliper

    subcutaneous fat outcome measure

    Time frame: Pretreatment and Posttreatment of six weeks study protocol.

Secondary outcomes

  1. Lipid profile

    Low-density lipoprotein, High-density lipoprotein, and triglyceride laboratory outcome measures.

    Time frame: Pretreatment and Posttreatment of six weeks study protocol.

07

Study locations

1 site
  • Helwan General Hospital
    Cairo, Helwan, Cairo Governate 02, Egypt
08

References and documents

Individual participant data

Plan to share: No — Will Share whole raw data, therapeutic protocol details for future systematic review and/ or meta-analysis. wish to be valuable

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06290674
Lead sponsor
Cairo University
Responsible party
Amany Ezzat Abbass Ali (Physical Therapy, Cairo University) — Principal investigator
First posted
Mar 4, 2024
Start date
Sep 11, 2022
Primary completion
Jan 1, 2024
Completion
Feb 1, 2024
Last update
Jul 22, 2024

Study contacts

Azza B Nashed, PHD
study chair · Professor of Physical Therapy for Women's Health
Sherif S El-Shebeni, MSc.
study director · Consultant of Obstetrics and Gynecology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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