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
  Purpose

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.


Condition Intervention Phase
Obesity
Cardiovascular Disease
Type 2 Diabetes
Dietary Supplement: Alpha Lipoic Acid
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALA
alpha lipoic acid 1200 mg/day
Dietary Supplement: Alpha Lipoic Acid
1200 mg/day
Other Name: Lipoic acid
Placebo Comparator: Placebo
placebo 1200 mg/day
Dietary Supplement: Placebo
1200 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994513

Locations
China, Xinjiang
Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
Sponsors and Collaborators
Georgia Regents University
Xinjiang Medical University
  More Information

No publications provided

Responsible Party: Xiaoling Wang, Assistant Professor, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00994513     History of Changes
Other Study ID Numbers: HAC08-07-02
Study First Received: October 13, 2009
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Antioxidant
Obesity

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Obesity
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014