Incretin Effect in PCOS Women

Polycystic Ovary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892254
• Other study ID #: PCOS-INK
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: November 23, 2017

Study information

• Verified date: November 2020
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 23, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 %

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Metformin, 2x 2 tablets a day, 500 mg tablets
• Placebo
Placebo (to metformin)

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Gentofte	Hellerup	Select A State

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 12 weeks' treatment
Secondary	Glucagon response	Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs	0, 12 and 30 weeks