Incretin Effect in PCOS Women

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT01892254
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-30
• Study First Posted: 2013-07-04
• Primary Completion: 2017-11-23
• Study Completion: 2017-11-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin-Placebo	Placebo	Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
Placebo-metformin	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
Placebo-metformin	Placebo	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
Metformin-Placebo	Metformin	Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Copenhagen University Hospital Gentofte; 🇩🇰 Hellerup, Select A State, Denmark