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Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation

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ClinicalTrials.gov Identifier: NCT02105428
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic

Brief Summary:
A goal of this study is to use a novel methodology to determine whether insulin resistance in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with modifications. This could lead to future research to determine if these modifications interfere with their proper function. Additionally, the investigators will determine how protein quality is affected by exercise training. Aerobic exercise enhances the endogenous oxidant buffering systems which may minimize oxidative damage to proteins. The investigators propose that aerobic exercise minimizes the accrual of modified proteins by increasing the synthesis of new proteins, but also by increasing the degradation and removal of old and damaged proteins. Based on our previous studies the investigators observed that insulin affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only in muscle but also in liver. The investigators therefore propose that aerobic exercise and related increase in insulin sensitivity (and decline in insulin levels) will reduce accumulation of old and modified skeletal muscle and plasma proteins leading to improved function.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome (PCOS) Insulin Resistance Overweight Obese Behavioral: Aerobic Exercise Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation
Study Start Date : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Sedentary Control
Participants will be randomized to an exercise training program or sedentary control group. The sedentary will not perform any structured physical activity or exercise. Participants will be encouraged to maintain their sedentary lifestyle and will be monitored by an accelerometer to track physical activity.
Experimental: Aerobic Exercise Training
Participants will perform 12-weeks of aerobic exercise training
Behavioral: Aerobic Exercise Training
A progressive increase in duration, frequency and intensity so the last 8 weeks of exercise are performed for 60 min, 5 days per week and at 80% of aerobic capacity. The duration includes a 5 minute warm up and 5 minute cool down. All exercise will be performed on a stationary bicycle (i.e., cycle ergometer).




Primary Outcome Measures :
  1. Change in insulin sensitivity [ Time Frame: Measured before and after 12 weeks ]
    To determine the effect of 12 weeks of aerobic exercise training or sedentary behavior on insulin sensitivity measured by a 3 hour hyperinsulinemic-euglycemic clamp and response to a mixed-meal.


Secondary Outcome Measures :
  1. Protein modifications and accumulation [ Time Frame: Before and after 12 weeks ]
    Alterations in protein modifications and accumulation will be measured by a novel methodology developed within our laboratory. Infusion of stable amino acid isotopes will be used to measure the accumulation of proteins before and after 12 weeks of aerobic exercise training or sedentary behavior. Plasma and muscle will be resolved using a two dimensional gel electrophoresis which will allow the identification of protein modifications and age.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. BMI between 25 kg/m2 and 40 kg/m2
  2. Fasting blood glucose < 126 mg/dL
  3. Diagnosed with PCOS as outlined by the Rotterdam criteria
  4. Insulin resistant as determined by a 3 hour oral glucose tolerance test

Exclusion Criteria:

  1. Serum creatinine ≥1.5 mg/ dL.
  2. Serum transaminase elevation ≥ 3 times the upper limit of normal range
  3. Use of systemic glucocorticoids
  4. Use of oral anticoagulation
  5. Pregnancy

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): NCT02105428


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Responsible Party: K. Sreekumaran Nair, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02105428    
Other Study ID Numbers: 09-007006
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by K. Sreekumaran Nair, Mayo Clinic:
Polycystic Ovarian Syndrome (PCOS)
Insulin Resistance
Overweight, Obese Women
Protein Metabolism
Post Translational Modifications
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases