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Incretin Effect in PCOS Women

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ClinicalTrials.gov Identifier: NCT01892254
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Louise Vedtofte, 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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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 Start Date : June 2013
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : November 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin-Placebo
Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
Drug: Metformin
Metformin, 2x 2 tablets a day, 500 mg tablets

Drug: Placebo
Placebo (to metformin)

Placebo Comparator: Placebo-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
Drug: Metformin
Metformin, 2x 2 tablets a day, 500 mg tablets

Drug: Placebo
Placebo (to metformin)




Primary Outcome Measures :
  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 Outcome Measures :
  1. Glucagon response [ Time Frame: 0, 12 and 30 weeks ]
    Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 %

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892254


Locations
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Denmark
Copenhagen University Hospital Gentofte
Hellerup, Select A State, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Principal Investigator: Louise Vedtofte, Cand.scient., PhD Copenhagen University Hospital, Gentofte

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Responsible Party: Louise Vedtofte, Humanbiolog, ph.d., University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01892254     History of Changes
Other Study ID Numbers: PCOS-INK
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Keywords provided by Louise Vedtofte, University Hospital, Gentofte, Copenhagen:
incretin effect
PCOS
insulin resistance
OGTT
IIGI
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists