ObesityPhase 4NCT00883259
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
A Phase 4 study testing Metformin in people with Obesity and Polycystic Ovary Syndrome, run by University Magna Graecia at 3 sites in Italy.
Trial summary
Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with gestational DM are likely to have underlying polycystic ovarian morphology. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity, Polycystic Ovary Syndrome, Gestational Diabetes
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with Polycystic Ovary Syndrome (using ASRM/ESHRE criteria)
- BMI > 30
- Previous diagnosis of gestational DM
Who cannot join
- Major medical conditions
- Organic pelvic diseases
- Previous pelvic surgery
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Pugliese Hospital
Catanzaro, Catanzaro, CZ, 88100
"Pugliese" Hospital
Catanzaro, Catanzaro, 88100
Ingrid Tomaino, MD, +39-0961-883234, angela.falbo@libero.it
University of Catanzaro, Italy
Catanzaro, 88100
About this study
Official title: Metformin Treatment for Preventing Gestational Diabetes in High-risk Patients
Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with gestational DM are likely to have underlying polycystic ovarian morphology. A recent meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population.
Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently introduced to treat PCOS.
Read more
At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS patients showing benefits for maternal and fetal outcomes, without serious adverse events. Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking, thus it is not possible to either suggest or advice against the use of metformin during pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing model of "high-risk patients" to evaluate the efficacy of metformin for preventing DM development.
The present protocol firstly will evaluate the effects of metformin administration in reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.
Read the detailed description
Obese pregnant PCOS patients with previous diagnosis of gestational DM will be enrolled and allocated into two treatment arms (experimental and placebo groups). Subjects in the experimental group will receive metformin at dosage of 850 mg twice daily, whereas subjects in the control group will receive placebo tablets (microcristallyne cellulose) twice daily.
At baseline, all subjects will undergo clinical evaluation, serial ultrasound examinations, and venous blood drawing to evaluate complete hormonal assays and serum fasting glucose and insulin levels. The homeostasis model of assessment-insulin resistance, the fasting glucose-to-insulin ratio, and the free androgen index will be also calculated. Monthly follow-up visits will be performed for assessing maternal and fetal wellbeing.
The primary endpoint of the study will be the incidence of gestational DM. The power analysis and the sample size calculation, performed using SamplePower release 2.0, showed that we will need to enroll at least 40 patients for each group to yield a statistically significant result with a power study of 90%. For categorical variables, the Pearson chi-square test will be performed. Continuous data will be expressed either as mean and standard deviation or median and inter-quartile range with min-max values, according to their normal distribution, and analysed using the Student t test or Mann-Whitney U test, respectively. Statistical significance will be set at P<0.05. The Statistics Package for Social Science (SPSS 14.0.1; Chicago, IL, USA) will be used for statistical analysis.
- Conditions
- Obesity, Polycystic Ovary Syndrome, Gestational Diabetes
- Being tested
- Metformin, Placebo
- Keywords
- High-risk patients, Metformin, PCOS, Pregnancy complications, Previous gestational DM
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome, Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
850 mg twice daily
PlaceboOther
Microcristallyne cellulose 1 table twice daily
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Metformin treatment Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gestational DM in high-risk patients
Measured: 36 months
Secondary outcomes (7)
Abortion
Measured: 36 months
Pregnancy-induced hypertension
Measured: 36 months
Pre-eclampsia
Measured: 36 months
Macrosomia
Measured: 36 months
Fetal malformations
Measured: 36 months
Premature deliveries
Measured: 36 months
Intrauterine deaths
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
- Investigators
- Stefano Palomba, MD, Principal investigator, Department of Obstetrics & Gynecology - University Magna Graecia of CatanzaroFrancesco Orio, MD, Principal investigator, Endocrinology - University " Parthenope" of NaplesAchille Tolino, MD, Principal investigator, Department of Obstetrics & Gynecology, University of NaplesTommaso Simoncini, MD, Principal investigator, Department of Obstetrics & Gynecology - University of PisaFulvio Zullo, MD, Principal investigator, Gynecologic Unit, Cancer Center of Excellence "Tommaso Campanella" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883259
- Sponsor's protocol ID
- 12/2008
- Status last verified
- Apr 2013
- First submitted
- 16 Apr 2009
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Treatment for Preventing Gestational Diabetes in High-risk Patients
- ClinicalTrials.gov ID
- NCT00883259
- Acronym / sponsor ID
- 12/2008
- Conditions
- Obesity, Polycystic Ovary Syndrome, Gestational Diabetes
- Keywords
- High-risk patients, Metformin, PCOS, Pregnancy complications, Previous gestational DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 17 Apr 2009 (estimated)
- 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.
Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with gestational DM are likely to have underlying polycystic ovarian morphology. A recent meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population.
Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently introduced to treat PCOS.
At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS patients showing benefits for maternal and fetal outcomes, without serious adverse events. Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking, thus it is not possible to either suggest or advice against the use of metformin during pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing model of "high-risk patients" to evaluate the efficacy of metformin for preventing DM development.
The present protocol firstly will evaluate the effects of metformin administration in reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.
Detailed description
Obese pregnant PCOS patients with previous diagnosis of gestational DM will be enrolled and allocated into two treatment arms (experimental and placebo groups). Subjects in the experimental group will receive metformin at dosage of 850 mg twice daily, whereas subjects in the control group will receive placebo tablets (microcristallyne cellulose) twice daily.
At baseline, all subjects will undergo clinical evaluation, serial ultrasound examinations, and venous blood drawing to evaluate complete hormonal assays and serum fasting glucose and insulin levels. The homeostasis model of assessment-insulin resistance, the fasting glucose-to-insulin ratio, and the free androgen index will be also calculated. Monthly follow-up visits will be performed for assessing maternal and fetal wellbeing.
The primary endpoint of the study will be the incidence of gestational DM. The power analysis and the sample size calculation, performed using SamplePower release 2.0, showed that we will need to enroll at least 40 patients for each group to yield a statistically significant result with a power study of 90%. For categorical variables, the Pearson chi-square test will be performed. Continuous data will be expressed either as mean and standard deviation or median and inter-quartile range with min-max values, according to their normal distribution, and analysed using the Student t test or Mann-Whitney U test, respectively. Statistical significance will be set at P<0.05. The Statistics Package for Social Science (SPSS 14.0.1; Chicago, IL, USA) will be used for statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: MetforminMetformin treatment |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women with Polycystic Ovary Syndrome (using ASRM/ESHRE criteria)
- BMI > 30
- Previous diagnosis of gestational DM
Key exclusion criteria (3 listed)
- Major medical conditions
- Organic pelvic diseases
- Previous pelvic surgery
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 |
|---|---|---|
| Metformin850 mg twice daily | Drug | Experimental |
| PlaceboMicrocristallyne cellulose 1 table twice daily | Other | Placebo |
Primary outcome
Incidence of gestational DM in high-risk patients
Time frame: 36 months
7 secondary outcomes
Abortion
Time frame: 36 months
Pregnancy-induced hypertension
Time frame: 36 months
Pre-eclampsia
Time frame: 36 months
Macrosomia
Time frame: 36 months
Fetal malformations
Time frame: 36 months
Premature deliveries
Time frame: 36 months
Intrauterine deaths
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
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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.
Stefano Palomba, MD principal investigator
Department of Obstetrics & Gynecology - University Magna Graecia of Catanzaro
Francesco Orio, MD principal investigator
Endocrinology - University " Parthenope" of Naples
Achille Tolino, MD principal investigator
Department of Obstetrics & Gynecology, University of Naples
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Obesity and Polycystic Ovary Syndrome, run by University Magna Graecia at 3 sites in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Palomba, MD (+39-0961-883234, stefanopalomba@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gestational DM in high-risk patients (time frame: 36 months). 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 8 Apr 2013.