Incretin Effect in PCOS Women

University Hospital, Gentofte, Copenhagen20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

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

PlaceboDRUG

Placebo (to metformin)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 %

Locations (1)

Copenhagen University Hospital Gentofte

Hellerup, Select A State, Denmark

Outcomes

Primary Outcomes

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

Time frame: baseline and 12 weeks' treatment

Secondary Outcomes

Glucagon response

Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs

Time frame: 0, 12 and 30 weeks

Data from ClinicalTrials.gov

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