NCT00857376

Brief Summary

Heart disease is the most common cause of death in the United States and it is commonly found in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter product, reduces blood levels of markers of oxidative stress and inflammation when compared with placebo. Placebo is a substance that looks like the real product, but contains no active product.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

4.4 years

First QC Date

March 4, 2009

Last Update Submit

September 27, 2012

Conditions

Metabolic Syndrome

Keywords

Heart disease risk factorsRisk factor managementPre-DiabetesHypertensionobesityglucose intolerancehigh cholesterolabdominal obesityenlarged waist

Outcome Measures

Primary Outcomes (1)

  • This study will provide information on the effect of a dose range of ALA on oxidative stress biomarkers.

    3 months

Secondary Outcomes (1)

  • To determine whether ALA improves vascular function through its effects on oxidative stress

    3 months

Study Arms (4)

placebo

PLACEBO COMPARATOR

Placebo 2 tabs three times daily

Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo

Alpha lipoic acid 1

EXPERIMENTAL

Alpha lipoic acid 600 mg daily

Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo

Alpha lipoic acid 2

EXPERIMENTAL

Alpha Lipoic acid 1200 mg daily

Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo

Alpha lipoic acid 3

EXPERIMENTAL

Alpha lipoic acid 1800 mg daily

Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo

Interventions

Alpha lipoic acid at 3 doses compared to placeboDIETARY_SUPPLEMENT

This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.

Alpha lipoic acid 1Alpha lipoic acid 2Alpha lipoic acid 3placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 or more yrs,
  • Are able to give informed consent
  • Diabetic on stable doses of oral medications or diet or
  • Metabolic syndrome defined as having 3 or more of the following:
  • Impaired or fasting glucose \> or = 100 mg/dL) or impaired glucose tolerance
  • Waist circumference \> 40 inches in men and \> 35 inches in women,
  • Hypertension (\> or = 130/85 mmHg) or are on antihypertensive medication,
  • LDL \< or = 50 mg/dL in females and \< or = 40 mg/dL in men,
  • Triglyceride \> or = 150 mg/dL

You may not qualify if:

  • Are on oral hypoglycemic drugs or insulin with HbA1c \> 7.5,if diabetic,
  • On antioxidant supplementation and are unable or unwilling to stop,
  • A woman on hormone replacement therapy,
  • On medications that may have antioxidant or anti-inflammatory effects or effects on insulin sensitivity, e.g. HMGCo-A reductase inhibitor that cannot be discontinued for the duration of the study,
  • Current smoker (within 3 months prior to enrollment),
  • Have known coronary artery disease or stroke,
  • Have other diseases associated with active inflammation e.g. connective tissue disease, malignancy,
  • have a CRP \> or = 10 mg/dl on screening blood with clinical evidence of inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeGlucose IntoleranceHypertensionObesityHypercholesterolemiaObesity, Abdominal

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemiaVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Pamela Ouyang, MBBS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2008

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

October 1, 2012

Record last verified: 2012-09