Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 566 for:    "Polycystic Ovary Syndrome"

Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02086526
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Alice Y Chang, Mayo Clinic

Brief Summary:
The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Phase 1

Detailed Description:
The investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. This project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. This pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to National Institutes of Health (NIH).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Targeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype
Study Start Date : March 2014
Actual Primary Completion Date : November 20, 2016
Actual Study Completion Date : November 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin
Metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
Drug: Metformin
Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
Other Name: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Delayed Start Metformin
After baseline study visit, this arm will return after three months without metformin for a repeat of the baseline study visit prior to initiating metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
Drug: Metformin
Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
Other Name: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet




Primary Outcome Measures :
  1. Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy [ Time Frame: Baseline, 3 months ]
    Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.


Secondary Outcome Measures :
  1. Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy [ Time Frame: baseline, 3 months ]
    The ratio of Peripheral Digital Arterial Tonometry (PAT) signal after cuff release compared with baseline is calculated through a computer algorithm normalizing for baseline measurements and indexing to measurements in the contra-lateral arm. The calculated ratio reflects the reactive hyperemia index (RHI).


Other Outcome Measures:
  1. Change in Weight [ Time Frame: baseline, 3 months ]
  2. Change in Testosterone [ Time Frame: baseline, 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) greater than or equal to 25
  • Polycystic Ovary Syndrome criteria of both oligomenorrhea (<9 menses per year) and androgen excess [clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone].
  • Taking no medications for the treatment of insulin resistance.

Exclusion Criteria:

  • Diagnosis of Cushing's syndrome
  • Untreated hypo/hyperthyroidism
  • Elevated prolactin
  • Congenital adrenal hyperplasia
  • Renal insufficiency (creatinine > 1.5)
  • Diabetes
  • Medications that can significantly affect endothelial function
  • Pregnancy
  • Breast Feeding
  • Taking oral contraceptives
  • Currently smoking

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): NCT02086526


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Alice Chang, MD Mayo Clinic

Layout table for additonal information
Responsible Party: Alice Y Chang, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02086526     History of Changes
Other Study ID Numbers: 13-000692
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs