NCT00994513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

October 13, 2009

Last Update Submit

September 23, 2010

Conditions

ObesityCardiovascular DiseaseType 2 Diabetes

Keywords

AntioxidantObesity

Outcome Measures

Primary Outcomes (3)

  • Biomarkers of oxidative stress

    2 months

  • Insulin sensitivity

    2 months

  • Endothelial function

    2 months

Secondary Outcomes (4)

  • Inflammatory markers

    2 months

  • Blood pressure

    2 months

  • Fasting lipid profile

    2 months

  • Pulse wave velocity

    2 months

Study Arms (2)

ALA

ACTIVE COMPARATOR

alpha lipoic acid 1200 mg/day

Dietary Supplement: Alpha Lipoic Acid

Placebo

PLACEBO COMPARATOR

placebo 1200 mg/day

Dietary Supplement: Placebo

Interventions

Alpha Lipoic AcidDIETARY_SUPPLEMENT

1200 mg/day

Also known as: Lipoic acid
ALA
PlaceboDIETARY_SUPPLEMENT

1200 mg/day

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • years old
  • Not on any antioxidant vitamin supplement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

MeSH Terms

Conditions

ObesityCardiovascular DiseasesDiabetes Mellitus, Type 2

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

CN(1)