- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505427
Alpha Lipoic Acid and Polycystic Ovary Syndrome
The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp. Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids and markers of oxidative stress will be measured. They will then receive open label controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative stress will be repeated.
Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative stress, testosterone levels and improve cardiovascular risk factors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California at San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PCOS diagnosis
- 18 years of age or older
- Body Mass Index below 35
- Willing to use any form of contraception for the duration of the study
Exclusion Criteria:
- Diabetes
- Pregnancy
- Liver or heart disease or other health problems
- Taking medications that affect insulin resistance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Umesh Masharani, MD, University of California, San Francisco
- Principal Investigator: Ira Goldfine, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hyperinsulinism
- Polycystic Ovary Syndrome
- Syndrome
- Insulin Resistance
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
Other Study ID Numbers
- 8476-27691-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insulin Resistance
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedEndoplasmic Reticulum Stress | HIV Related Insulin Resistance | Protease Inhibitor Related Insulin ResistanceUnited States
-
Paloma Almeda-ValdésCompleted
-
National Institute of Diabetes and Digestive and...Active, not recruitingSevere Insulin ResistanceUnited States
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
German Diabetes CenterYale UniversityRecruiting
-
Assiut UniversityCompleted
-
National Taiwan UniversityNational Cheng-Kung University HospitalCompletedExercise, Insulin Resistance, Visceral Adipose TissueTaiwan
-
University Health Network, TorontoCompletedInsulin Resistance Syndrome X | Pancreatic Beta Cell FunctionCanada
-
The University of Texas Medical Branch, GalvestonCompletedInsulin Resistance, DiabetesUnited States
-
University Health Network, TorontoCompletedInsulin Resistance, DiabetesCanada
Clinical Trials on Alpha Lipoic Acid
-
InVasc Therapeutics, Inc.CompletedHypertension | DiabetesUnited States
-
Khyber Medical University PeshawarActive, not recruitingPeripheral Diabetic NeuropathyPakistan
-
Rebecca SpainCompletedComparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisProgressive Multiple Sclerosis | Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Heba Allah Ali Abd El-Halim MabroukTanta UniversityUnknown
-
Seoul St. Mary's HospitalGlaxoSmithKlineTerminatedNASH (Non-alcoholic Steato-hepatitis)
-
Augusta UniversityXinjiang Medical UniversityCompletedObesity | Cardiovascular Disease | Type 2 DiabetesChina
-
University Health Network, TorontoCanadian Diabetes AssociationCompletedType 2 Diabetes | PrediabetesCanada
-
Oregon State UniversityOregon Health and Science University; National Center for Complementary and...Active, not recruiting
-
University of British ColumbiaRecruitingObstructive Sleep Apnea of AdultCanada