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Completed

NCT Number: NCT00994513

Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha Lipoic Acid

Dietary Supplement

1200 mg/day

Other names: Lipoic acid

Placebo

Dietary Supplement

1200 mg/day

Primary outcomes

  1. Biomarkers of oxidative stress

    Time frame: 2 months

  2. Insulin sensitivity

    Time frame: 2 months

  3. Endothelial function

    Time frame: 2 months

Secondary outcomes

  1. Inflammatory markers

    Time frame: 2 months

  2. Blood pressure

    Time frame: 2 months

  3. Fasting lipid profile

    Time frame: 2 months

  4. Pulse wave velocity

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • Xinjiang Medical University

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Sep 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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