The effect of metformin and myoinositol in women with polycystic ovary syndrome: role of body mass and adiponectin
| ISRCTN | ISRCTN13199265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13199265 |
- Submission date
- 04/04/2021
- Registration date
- 14/04/2021
- Last edited
- 20/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman's ovaries work. The 3 main features of PCOS are:
1. Irregular periods – which means your ovaries do not regularly release eggs (ovulation)
2. Excess androgen – high levels of "male" hormones in your body, which may cause physical signs such as excess facial or body hair
3. Polycystic ovaries – your ovaries become enlarged and contain many fluid-filled sacs (follicles) that surround the eggs (but despite the name, you do not actually have cysts if you have PCOS)
The aim of this study is to compare the effects of six months of treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in women affected by polycystic ovary syndrome. The study group includes 66 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 4000 mg/day). The investigations include body composition indices and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, adiponectine and lipid profile at baseline and after six months of treatment.
Who can participate?
Adult females aged between 18 and 40 who have PCOS diagnosis
What does the study involve?
Initially, potential participants will be invited for a screening test where the researchers will measure their weight, height, waist, and hips and explain the study in detail to them. After successful screening, if they are still interested in taking part, they will come into University Clinical Centre Banja Luka, in the morning, having fasted overnight (for 12 hours). The researchers will take several blood samples from this throughout the day 30 ml of blood will be taken at six times throughout the 2 hours; a total of 180 ml of blood. A bed will be provided to rest on.
What are the possible benefits and risks of participating?
There are no notable benefits for those involved in the study. They will get the opportunity to learn about research in this area. Furthermore, their participation in this project may help to contribute to a better understanding of the effects of insulin sensitizers on changes in adipose tissue. This information may ultimately be important in the long-term to help to develop more effective strategies to treat PCOS and prevent diabetes and cardiovascular disease in later age.
Whilst there are no risks, some people may find it uncomfortable to give blood samples. They can be assured that the researchers are experienced and will ensure they are comfortable with all procedures and assessments. Women who become pregnant over the course of the study must inform the investigator and leave the study immediately. Drugs used in the study have been already registered by State Agency for drugs and have been part of standard treatments of PCOS. If at any stage they have an adverse reaction, they should stop taking the drug and immediately inform the researcher who will instruct them on what to do.
Where is the study run from?
University Clinical Centre of Republic of Srpska (Bosnia and Herzegovina)
When is the study starting and how long is t expected to run for?
November 2017 to May 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Valentina Soldat-Stankovic
valentinasoldatstankovic@yahoo.com
Contact information
Scientific
Ivana Kukuljevica 16
Banja Luka
78000
Bosnia and Herzegovina
 ORCID ID |
0000-0002-9858-5646 |
|---|---|
| Phone | +387 65617019 |
| valentina.soldat@kc-bl.com |
Study information
| Study design | Single centre randomized open-label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN13199265_PIS.pdf |
| Scientific title | The effect of metformin and myoinositol on metabolic outcomes in women with polycystic ovary syndrome: role of body mass and adiponectin in a randomized controlled trial |
| Study objectives | Six months therapy with different insulin sensitive compounds can influence changes in body mass and adiponectin in PCOS women |
| Ethics approval(s) | Approved 06/10/2016, University Clinical Centre of Republic of Srpska Ethics Committee (Office of Research Ethics, University Clinical Centre of Republic of Srpska Banja Luka, 12 beba bb, Bosnia and Herzegovina; +387 51 310 530; info@kc-bl.com), ref: 01-9-742.2/16 |
| Health condition(s) or problem(s) studied | Polycystic ovary syndrome |
| Intervention | The study group includes 66 patients (33 lean and 33 overweight/obese) with PCOS, Participants will be randomly allocated into treatment groups in a 1:1 ratio using stratification by body mass index (≤25 kg/m² or >25 kg/m²). All 33 patients from each study group will receive either 2g myoinositol (MI) plus 200 mcg folic acid twice daily or metformin (MET) 500 mg thrice daily for 6 months, respectively. After the successful screening, if they are still interested in taking part, they will come into the Endocrinology Clinic, in the morning, having fasted overnight (for 9 hours). In all subjects, Body mass index, waist circumference and hirsutism score will be determined at the first visit and at the 6-month endpoint. Body composition will be estimated by using bioelectrical impedance analysis. Upon enrollment, all patients will also undergo transvaginal ultrasonography. Baseline blood samples will be collected after 12 hours of fasting during the early follicular phase for hormonal assessment, insulin and glucose during 120 min OGTT test, adiponectin, lipid profile and hsCRP. At the end of a six-month investigation period, clinical and biochemical evaluation was repeated. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | myoinositol, folic acid, metformin |
| Primary outcome measure | 1. Adiponectin measured using blood test at baseline and six months (after 12 hours of fasting) |
| Secondary outcome measures | 1. Body mass index (kg/m²) and body composition changes measured by bioelectrical impedance at baseline and six months 2. Testosterone level measured using blood test at baseline and six months (after 12 hours of fasting) 3. Glyco-insulinemic metabolism measured using area under the curve insulin post oral glucose tolerance test (AUC insulin), area under the curve glucose post oral glucose tolerance test (AUC glucose), quantitative insulin sensitivity check index QUICKI and homeostasis model assessment index HOMA IR at baseline and six months (after 12 hours of fasting) 4. Improvement/deterioration of clinical symptoms: hyperandrogenic features measured by Ferriman Gallwey score at baseline and six months |
| Overall study start date | 06/10/2016 |
| Completion date | 05/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 66 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003 2. Age 18 - 40 years |
| Key exclusion criteria | 1. Significant liver or renal impairment 2. Other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs) 3. History of drug and alcohol abuse 4. History of breast and uterine cancer 5. Diagnosis of diabetes mellitus 6. Use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study |
| Date of first enrolment | 09/11/2017 |
| Date of final enrolment | 20/11/2018 |
Locations
Countries of recruitment
- Bosnia and Herzegovina
Study participating centre
Banja Luka
78000
Bosnia and Herzegovina
Sponsor information
Hospital/treatment centre
12 beba bb
Banja Luka
78000
Bosnia and Herzegovina
| Phone | +387 51310530 |
|---|---|
| info@kc-bl.com | |
| Website | http://kc-bl.com/En/ |
"ROR" |
https://ror.org/05vapw332 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents are not available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Upon request, the corresponding author will provide access to individual de-identified participant data, Study protocol, Informed consent form. Data may be requested from corresponding author beginning 3 months and ending 5 years following article publication. All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes | ||
| Results article | 19/10/2021 | 20/10/2021 | Yes | No |
Additional files
- ISRCTN13199265_PIS.pdf
- uploaded 04/05/2021
Editorial Notes
20/10/2021: Publication reference added.
03/06/2021: The intention to publish date was changed from 01/06/2021 to 01/09/2021.
04/05/2021: The participant information sheet was uploaded as an additional file.
14/04/2021: Trial's existence confirmed by University Clinical Centre of Republic of Srpska Ethics Committee.
