- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994513
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
September 23, 2010 updated by: Augusta University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Xinjiang
-
Urumqi, Xinjiang, China, 830054
- Xinjiang Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ALA
alpha lipoic acid 1200 mg/day
|
1200 mg/day
Other Names:
|
Placebo Comparator: Placebo
placebo 1200 mg/day
|
1200 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarkers of oxidative stress
Time Frame: 2 months
|
2 months
|
Insulin sensitivity
Time Frame: 2 months
|
2 months
|
Endothelial function
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inflammatory markers
Time Frame: 2 months
|
2 months
|
Blood pressure
Time Frame: 2 months
|
2 months
|
Fasting lipid profile
Time Frame: 2 months
|
2 months
|
Pulse wave velocity
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 13, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 14, 2009
Study Record Updates
Last Update Posted (Estimate)
September 24, 2010
Last Update Submitted That Met QC Criteria
September 23, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAC08-07-02
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.
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