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Incretin Effect in PCOS Women

NCT ID: NCT01892254

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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incretin effect PCOS insulin resistance OGTT IIGI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metformin-Placebo

Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin, 2x 2 tablets a day, 500 mg tablets

Placebo

Intervention Type DRUG

Placebo (to metformin)

Placebo-metformin

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

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

Metformin, 2x 2 tablets a day, 500 mg tablets

Placebo

Intervention Type DRUG

Placebo (to metformin)

Interventions

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Metformin

Metformin, 2x 2 tablets a day, 500 mg tablets

Intervention Type DRUG

Placebo

Placebo (to metformin)

Intervention Type DRUG

Other Intervention Names

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657-24-9

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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 %
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Louise Vedtofte

Humanbiolog, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Vedtofte, MSc., PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

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Copenhagen University Hospital Gentofte

Hellerup, Select A State, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PCOS-INK

Identifier Type: -

Identifier Source: org_study_id