Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation

NCT02105428 | Completed

• 1 other identifier: 09-007006
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome (PCOS); Insulin Resistance; Overweight; Obese

Keywords

Polycystic Ovarian Syndrome (PCOS); Insulin Resistance; Overweight, Obese Women; Protein Metabolism; Post Translational Modifications

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

  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.

  Measured before and after 12 weeks

Secondary Outcomes (1)

• Protein modifications and accumulation

  Before and after 12 weeks

Study Arms (2)

Sedentary Control

NO INTERVENTION

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.

Aerobic Exercise Training

EXPERIMENTAL

Participants will perform 12-weeks of aerobic exercise training

Behavioral: Aerobic Exercise Training

Interventions

Aerobic Exercise Training BEHAVIORAL

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).

Aerobic Exercise Training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)