Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

NCT ID: NCT00994513

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Obesity Cardiovascular Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALA

alpha lipoic acid 1200 mg/day

Group Type ACTIVE_COMPARATOR

Alpha Lipoic Acid

Intervention Type DIETARY_SUPPLEMENT

1200 mg/day

Placebo

placebo 1200 mg/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1200 mg/day

Interventions

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Alpha Lipoic Acid

1200 mg/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

1200 mg/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lipoic acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xinjiang Medical University

OTHER

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Medical College of Georgia

Locations

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Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Countries

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China

Other Identifiers

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HAC08-07-02

Identifier Type: -

Identifier Source: org_study_id