ObesityPhase 2/3NCT00994513
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
A Phase 2/3 study testing Alpha Lipoic Acid in people with Obesity and Cardiovascular Disease, run by Augusta University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease, Type 2 Diabetes
- What is being tested?
- Alpha Lipoic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to May 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Cardiovascular Disease, Type 2 Diabetes
- Being tested
- Alpha Lipoic Acid, Placebo
- Keywords
- Antioxidant, Obesity
- Medical subject headings
- Obesity, Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic AcidDietary supplement
Also called Lipoic acid
1200 mg/day
PlaceboDietary supplement
1200 mg/day
| Study group | Role | What they receive |
|---|---|---|
| ALA | Active comparator | alpha lipoic acid 1200 mg/day Receives: Dietary Supplement: Alpha Lipoic Acid |
| Placebo | Placebo comparator | placebo 1200 mg/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of oxidative stress
Measured: 2 months
Insulin sensitivity
Measured: 2 months
Endothelial function
Measured: 2 months
Secondary outcomes (4)
Inflammatory markers
Measured: 2 months
Blood pressure
Measured: 2 months
Fasting lipid profile
Measured: 2 months
Pulse wave velocity
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994513
- Sponsor's protocol ID
- HAC08-07-02
- Status last verified
- Sep 2010
- First submitted
- 13 Oct 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
- ClinicalTrials.gov ID
- NCT00994513
- Acronym / sponsor ID
- HAC08-07-02
- Conditions
- Obesity, Cardiovascular Disease, Type 2 Diabetes
- Keywords
- Antioxidant, Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Xinjiang Medical University
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA | Active comparator | Dietary Supplement: Alpha Lipoic Acidalpha lipoic acid 1200 mg/day |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo 1200 mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic AcidAlso: Lipoic acid1200 mg/day | Dietary supplement | ALA |
| Placebo1200 mg/day | Dietary supplement | Placebo |
Primary outcome
Biomarkers of oxidative stress
Time frame: 2 months
Insulin sensitivity
Time frame: 2 months
Endothelial function
Time frame: 2 months
4 secondary outcomes
Inflammatory markers
Time frame: 2 months
Blood pressure
Time frame: 2 months
Fasting lipid profile
Time frame: 2 months
Pulse wave velocity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alpha Lipoic Acid in people with Obesity and Cardiovascular Disease, run by Augusta University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of oxidative stress (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.