Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

This study has been completed.

Sponsor:

Collaborator:

Xinjiang Medical University

Information provided by:

Georgia Regents University

ClinicalTrials.gov Identifier:

NCT00994513

First received: October 13, 2009

Last updated: September 23, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 13, 2009
Last Updated Date	September 23, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 23, 2010)	Biomarkers of oxidative stress [ Time Frame: 2 months ] [ Designated as safety issue: No ] Insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ] Endothelial function [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 13, 2009)	Biomarkers of oxidative stress [ Time Frame: 3 months ] [ Designated as safety issue: No ] Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ] Endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00994513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 23, 2010)	Inflammatory markers [ Time Frame: 2 months ] [ Designated as safety issue: No ] Blood pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ] Fasting lipid profile [ Time Frame: 2 months ] [ Designated as safety issue: No ] Pulse wave velocity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 13, 2009)	Inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ] Blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ] Fasting lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: No ] Pulse wave velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Official Title ^ICMJE	Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Brief Summary	The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Obesity Cardiovascular Disease Type 2 Diabetes
Intervention ^ICMJE	Dietary Supplement: Alpha Lipoic Acid 1200 mg/day Other Name: Lipoic acid Dietary Supplement: Placebo 1200 mg/day
Study Arm (s)	Active Comparator: ALA alpha lipoic acid 1200 mg/day Intervention: Dietary Supplement: Alpha Lipoic Acid Placebo Comparator: Placebo placebo 1200 mg/day Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	70
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Han ethnicity BMI≥25kg/m2 Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP<140mmHg or 85mmHg≤DBP<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L) 18-60 years old Not on any antioxidant vitamin supplement Exclusion Criteria: Pregnancy, lactation or child-bearing age without birth control device History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease Anything that would impede the subject from complying with the ALA treatment History of psychiatric problems
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00994513
Other Study ID Numbers ^ICMJE	HAC08-07-02
Has Data Monitoring Committee	Yes
Responsible Party	Xiaoling Wang, Assistant Professor, Medical College of Georgia
Study Sponsor ^ICMJE	Georgia Regents University
Collaborators ^ICMJE	Xinjiang Medical University
Investigators ^ICMJE	Not Provided
Information Provided By	Georgia Regents University
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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