Polycystic Ovary SyndromePhase 4NCT01892254
Incretin Effect in PCOS Women
A Phase 4 study testing Metformin in people with Polycystic Ovary Syndrome, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin. The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- 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
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to 23 Nov 2017
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with PCOS according to the Rotterdam criteria
- more than 18 years old
- BMI less than 30 kg/m2
- Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
- Negative GAD65 and islet cell autoantibodies
- Insulin resistant according to HOMA-IR
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- informed consent
- more than 18 years old
- BMI less than 30 kg/m2
- Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
- Negative GAD65 and islet cell autoantibodies
- informed consent
- regular menstrual cycle (28-35 days)
- Plasma androgen levels within reference levels
Who cannot join
- First or second degree relatives with diabetes
- pregnancy or breast feeding
- treatment with medication which influences the glucose metabolism (incl hormonal contraception)
- Congenital diseases which cause hyperandrogenism and irregular bleeding
- Known adrenal hyperplasia
- Known hyperprolaktinemia
- Alcohol consumption of more than 20 grams a day
- Hemoglobin less than 7.8 %
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Gentofte
Hellerup, Select A State, 2900
About this study
Official title: Inkretineffekten Hos Patienter Med Polycystisk Ovariesyndrom før og Efter Behandling af Insulinresistens (Incretin Effect in Patients With Polycystic Ovary Syndrome Before and After Treatment of Insulin Resistance)
This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin.
The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Placebo
- Keywords
- incretin effect, PCOS, insulin resistance, OGTT, IIGI
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called 657-24-9
Metformin, 2x 2 tablets a day, 500 mg tablets
PlaceboDrug
Placebo (to metformin)
| Study group | Role | What they receive |
|---|---|---|
| Metformin-Placebo | Experimental | Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo Receives: Drug: Metformin; Drug: Placebo |
| Placebo-metformin | Placebo comparator | Placebo tablets, 2x 2 tablets per day for 12 weeks, 6 weeks wash-out, 12 weeks metformin, 2x 2 tablets per day, 500 mg per tablet Receives: Drug: Metformin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in incretin effect from baseline and until after removal of insulin resistance
The incretin effect will be assessed from the insulin secretion during af 75 g OGTT and IIGI at baseline and after 12 weeks' treatment with placebo and metformin
Measured: baseline and 12 weeks' treatment
Secondary outcomes (1)
Glucagon response
Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs
Measured: 0, 12 and 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Vedtofte, University Hospital, Gentofte, Copenhagen
- Investigators
- Louise Vedtofte, MSc., PhD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892254
- Sponsor's protocol ID
- PCOS-INK
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2013
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inkretineffekten Hos Patienter Med Polycystisk Ovariesyndrom før og Efter Behandling af Insulinresistens (Incretin Effect in Patients With Polycystic Ovary Syndrome Before and After Treatment of Insulin Resistance)
- ClinicalTrials.gov ID
- NCT01892254
- Acronym / sponsor ID
- PCOS-INK
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- incretin effect, PCOS, insulin resistance, OGTT, IIGI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 4 Jul 2013 (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.
This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin.
The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin-Placebo | Experimental | Drug: Metformin, Drug: PlaceboMetformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo |
| Placebo-metformin | Placebo comparator | Drug: Metformin, Drug: PlaceboPlacebo tablets, 2x 2 tablets per day for 12 weeks, 6 weeks wash-out, 12 weeks metformin, 2x 2 tablets per day, 500 mg per tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosed with PCOS according to the Rotterdam criteria
- more than 18 years old
- BMI less than 30 kg/m2
- Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
- Negative GAD65 and islet cell autoantibodies
Key exclusion criteria (8 listed)
- First or second degree relatives with diabetes
- pregnancy or breast feeding
- treatment with medication which influences the glucose metabolism (incl hormonal contraception)
- Congenital diseases which cause hyperandrogenism and irregular bleeding
- Known adrenal hyperplasia
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 |
|---|---|---|
| MetforminAlso: 657-24-9Metformin, 2x 2 tablets a day, 500 mg tablets | Drug | Metformin-Placebo, Placebo-metformin |
| PlaceboPlacebo (to metformin) | Drug | Metformin-Placebo, Placebo-metformin |
Primary outcome
The change in incretin effect from baseline and until after removal of insulin resistance
Time frame: baseline and 12 weeks' treatment
The incretin effect will be assessed from the insulin secretion during af 75 g OGTT and IIGI at baseline and after 12 weeks' treatment with placebo and metformin
1 secondary outcome
Glucagon response
Time frame: 0, 12 and 30 weeks
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 27 Nov 2020.
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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.
Louise Vedtofte, MSc., PhD principal investigator
University Hospital, Gentofte, Copenhagen
1 site 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 Polycystic Ovary Syndrome, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 14 inclusion and 8 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 27 Nov 2020. 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 Denmark. 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?
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?
The change in incretin effect from baseline and until after removal of insulin resistance (time frame: baseline and 12 weeks' treatment). 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 27 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.