NCT01892254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

4.5 years

First QC Date

June 11, 2013

Last Update Submit

November 24, 2020

Conditions

Polycystic Ovary Syndrome

Keywords

incretin effectPCOSinsulin resistanceOGTTIIGI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Glucagon response

    0, 12 and 30 weeks

Study Arms (2)

Metformin-Placebo

EXPERIMENTAL

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

Drug: MetforminDrug: Placebo

Placebo-metformin

PLACEBO COMPARATOR

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

Drug: MetforminDrug: Placebo

Interventions

MetforminDRUG

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

Also known as: 657-24-9
Metformin-PlaceboPlacebo-metformin
PlaceboDRUG

Placebo (to metformin)

Metformin-PlaceboPlacebo-metformin

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Gentofte

Hellerup, Select A State, 2900, Denmark

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Louise Vedtofte, MSc., PhD

    University Hospital, Gentofte, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Humanbiolog, ph.d.

Study Record Dates

First Submitted

June 11, 2013

First Posted

July 4, 2013

Study Start

June 1, 2013

Primary Completion

November 23, 2017

Study Completion

November 23, 2017

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

DK(1)