Obesity, AbdominalNCT06290674
Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile
A study testing Extracorporeal Shockwave therapy and Balanced low-calorie diet in people with Obesity, Abdominal, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Extracorporeal Shockwave therapy and Balanced low-calorie diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile in Obese Postmenopausal Women
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.
- Conditions
- Obesity, Abdominal
- Being tested
- Extracorporeal Shockwave therapy, Balanced low-calorie diet
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave therapyOther
2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.
Balanced low-calorie dietOther
1500 k/cal for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study Group (A) (ESWT) | Active comparator | 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). Receives: Other: Extracorporeal Shockwave therapy; Other: Balanced low-calorie diet |
| Control Group (B) | Placebo comparator | 30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only. Receives: Other: Balanced low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist/ hip ratio
anthropometric outcome measure for abdominal adiposity
Measured: Pretreatment and Posttreatment of six weeks study protocol.
Skin fold caliper
subcutaneous fat outcome measure
Measured: Pretreatment and Posttreatment of six weeks study protocol.
Secondary outcomes (1)
Lipid profile
Low-density lipoprotein, High-density lipoprotein, and triglyceride laboratory outcome measures.
Measured: Pretreatment and Posttreatment of six weeks study protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start11 Sep 2022
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ezzat Abbass Ali, Cairo University
- Investigators
- Azza B Nashed, PHD, Study chair, Professor of Physical Therapy for Women's HealthSherif S El-Shebeni, MSc., Study director, Consultant of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290674
- Sponsor's protocol ID
- P.T.REC/012/004043
- Status last verified
- Jul 2024
- First submitted
- 26 Feb 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will Share whole raw data, therapeutic protocol details for future systematic review and/ or meta-analysis. wish to be valuable
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06290674
- Acronym / sponsor ID
- P.T.REC/012/004043
- Conditions
- Obesity, Abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Study Group (A) (ESWT) | Active comparator | Other: Extracorporeal Shockwave therapy, Other: Balanced low-calorie diet30 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). |
| Control Group (B) | Placebo comparator | Other: Balanced low-calorie diet30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave therapy2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session. | Other | Study Group (A) (ESWT) |
| Balanced low-calorie diet1500 k/cal for 6 weeks | Other | Control Group (B), Study Group (A) (ESWT) |
Primary outcome
Waist/ hip ratio
Time frame: Pretreatment and Posttreatment of six weeks study protocol.
anthropometric outcome measure for abdominal adiposity
Skin fold caliper
Time frame: Pretreatment and Posttreatment of six weeks study protocol.
subcutaneous fat outcome measure
1 secondary outcome
Lipid profile
Time frame: Pretreatment and Posttreatment of six weeks study protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No. Will Share whole raw data, therapeutic protocol details for future systematic review and/ or meta-analysis. wish to be valuable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave therapy and Balanced low-calorie diet in people with Obesity, Abdominal, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist/ hip ratio (time frame: Pretreatment and Posttreatment of six weeks study protocol.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.