Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
Study Details
Study Description
Brief Summary
this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) who were selected from the Outpatient Clinic of Gynecology at Qasr Al Aini University Hospital. Their age ranged from 17-28 years, body mass index was 25-30 Kg/m2. They experienced hyperandrogenism, hyperinsulinemia and amenorrhea not less than 6 months.
PCOS females will be randomly assigned into two equal groups: group (A) (control group) consisted of 30 women who received low caloric diet (1200 Cal/day) and group (B) (study group) consisted of 30 women who received the same diet regime and cryolipolysis
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: low caloric diet low caloric diet (1200cal/day) |
Dietary Supplement: low calolric diet
low caloric diet (1200cal/day)
|
Active Comparator: cryolipolysis cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device |
Device: 3max cool shaping device
cryolipolysis sessions are applied on abdomen area each session for 40 min. each
Dietary Supplement: low calolric diet
low caloric diet (1200cal/day)
|
Outcome Measures
Primary Outcome Measures
- Visceral adiposity index [3 months]
indicator of adipose tissue distribution
Secondary Outcome Measures
- weight [up to 3 months]
anthropometric measurement by kilogram (kg)
- waist circumference [up to 3 months]
anthropometric measurement by centimeter (cm)
- high density lipoprotein [up to 3 months]
blood test
- serum triglyceride level [up to 3months]
blood test
Eligibility Criteria
Criteria
Inclusion Criteria:
- age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome .
Exclusion Criteria:
-
Diabetic patients.
-
Women with BMI>30
-
Women having circulatory dysfunction.
-
Women with respiratory or cardiac disease
-
liver disease.
-
Skin disease .
-
Previous abdominal or uterine surgery
-
Physical impairment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cairo University | Cairo | Egypt | 14788 |
Sponsors and Collaborators
- Cairo University
Investigators
- Study Director: fahema me okiel, phd, Cairo University
- Study Chair: amal mo youssef, phd, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECVAPP