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Incretin Effect in PCOS Women

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring incretin effect, PCOS, insulin resistance, OGTT, IIGI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 %

Sites / Locations

  • Copenhagen University Hospital Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin-Placebo

Placebo-metformin

Arm Description

Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2013
Last Updated
November 24, 2020
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01892254
Brief Title
Incretin Effect in PCOS Women
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 23, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
incretin effect, PCOS, insulin resistance, OGTT, IIGI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin-Placebo
Arm Type
Experimental
Arm Description
Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
Arm Title
Placebo-metformin
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
657-24-9
Intervention Description
Metformin, 2x 2 tablets a day, 500 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (to metformin)
Primary Outcome Measure Information:
Title
The change in incretin effect from baseline and until after removal of insulin resistance
Description
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 Outcome Measure Information:
Title
Glucagon response
Description
Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs
Time Frame
0, 12 and 30 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 %
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Vedtofte, MSc., PhD
Organizational Affiliation
Copenhagen University Hospital, Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Gentofte
City
Hellerup
State/Province
Select A State
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Incretin Effect in PCOS Women

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