Incretin Effect in PCOS Women

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01892254

Enrollment

Registered

2013-07-04

Start date

2013-06-30

Completion date

2017-11-23

Last updated

2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

incretin effect, PCOS, insulin resistance, OGTT, IIGI

Brief 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 glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.

Interventions

DRUGMetformin

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

DRUGPlacebo

Placebo (to metformin)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

PCOS-women: * 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 Inclusion Criteria healthy women: * 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

PCOS and healthy women: * 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 %

Design outcomes

Primary

Measure	Time frame	Description
The change in incretin effect from baseline and until after removal of insulin resistance	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

Secondary

Measure	Time frame	Description
Glucagon response	0, 12 and 30 weeks	Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026