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OpenTrials
Completed

NCT Number: NCT01892254

Incretin Effect in PCOS Women

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital Gentofte

Hellerup, Select A State, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

metformin

Drug

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

Other names: 657-24-9

Placebo

Drug

Placebo (to metformin)

Primary outcomes

  1. 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

Secondary outcomes

  1. Glucagon response

    Time frame: 0, 12 and 30 weeks

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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2013
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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