Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201502001001110 Date of Approval: 18/01/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anti-inflammatory dietary combo in overweight and obese women with polycystic ovary syndrome
Official scientific title The effects of anti-inflammatory diet - in the context of lifestyle modification - with or without the use of metformin, on metabolic, endocrine, inflammatory and reproductive profiles in overweight and obese women with polycystic ovary syndrome
Brief summary describing the background and objectives of the trial Polycystic ovary syndrome (PCOS) is of clinical and public health importance, affecting up to one in five women of reproductive age.Recently a number of studies have focused on diet composition and weight loss in obese individuals, however, few of these studies have addressed the effects of varying diet composition on the obese PCOS population. Through the late nineties till the last few years, metformin had been used empirically by both gynecologists and dietitians in the management of PCOS patients as first line therapy. Thus we tested the hypotheses that: - Consumption of a hypocaloric low glycemic load (GL) diet with anti-inflammatory properties (our combo diet) would reduce total and visceral adipose tissue, promote weight loss, improve the reproductive, metabolic and hormonal profiles, and attain the patients¿ compliance. - With adding metformin to lifestyle modifications at a dose of 850 mg twice daily, we may get little superior effect to lifestyle modifications alone on; menstrual frequency, pregnancy rates, weight loss, reduction of insulin resistance or reduction of hyperandrogenism. - The possibility of using SAA as a surrogate marker obligating dietary intervention to combat metabolic and CV risks in overweight and obese patients with PCOS and its use as a prognostic indicator after lifestyle modification.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) quazi experimental
Disease(s) or condition(s) being studied Obstetrics and Gynecology,polycystic ovary syndrome
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/03/2012
Actual trial start date 01/03/2012
Anticipated date of last follow up 31/03/2013
Actual Last follow-up date 31/03/2013
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 220
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lifestyle modification (diet and exercise) every 2 weeks 12 weeks anti-inflammatory diet in the context of lifestyle modification in overweight and obese PCOS 100 Active-Treatment of Control Group
Experimental Group Lifestyle modification + Metformatin every 2 weeks 12 weeks Anti-inflammatory diet in the context of lifestyle in overweight and obese PCOS Plus Metformin 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Non-pregnant, overweight and obese adult females with PCOS, aged 20 ¿ 40 years The following subjects were excluded from the study: ¿ Subjects having type 1 or type 2 diabetes. ¿ Subjects receiving metformin within the last month. ¿ Subjects receiving ovulation induction medications within the last month. ¿ Subjects following a diet regimen within the last month. 20 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/02/2012 ethical commitee, High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
65 St., Al-Horeya Road alexandria 00203 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the effects of lifestyle modification with or without metformin on anthropometric, metabolic, endocrine and inflammatory markers in overweight and obese women with polycystic ovary syndrome. begining and end
Secondary Outcome To assess the effects of dietary recalibration, exercise and behavioural modification with or without metformin on regain of menstrual cyclicity and spontaneous pregnancy rates, and to compare the value of Acute-phase serum amyloid A as a surrogate marker for prognostic evaluation of the metabokic profile in overwight and obese women with PCOS in relation to C-reactive protein (CRP) beginning and end
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High Institute of Public Health, Alexandria University 65 St., Al-Horeya Road, Alexandria, Egypt Alexandria 00203 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self supported(amany salama) 48 Abd-Elsalam Aref St. Saba Basha. Alexandria 00203 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor amany salama 48 Abd-Elsalam Aref St. Saba Basha alex 00203 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ezzat K Amine 65 St., Al-Horeya Road Alexandria 00203 Egypt
Hesham A Salem 18 pharos st. Alexandria 00203 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Salama amanysalama@hotmail.com +2 1001637394 48 Abd-Elsaalam Aref St. Saba Basha
City Postal code Country Position/Affiliation
Alexandria Egypt
Role Name Email Phone Street address
Public Enquiries Amany Salama amanysalama@hotmial.com +1 1001637394 48 Abd.Elsalam Aref St. Saba Basha
City Postal code Country Position/Affiliation
Alexandria Egypt Women's Health and Nutrition Clinic
Role Name Email Phone Street address
Scientific Enquiries Ezzat K Amine ezzatamine@yahoo.com +2 1224440394 65 St., Al-Horeya Road
City Postal code Country Position/Affiliation
Alexandriea Egypt
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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