Diabetes Mellitus, Type 2Phase 2NCT00398892
The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
A Phase 2 study testing Lipoic acid in people with Diabetes Mellitus, Type 2, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar levels in people with type 2 diabetes. This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed on oral agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Jan 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Age > 18 years
- Capable of giving informed consent
- Treated with oral antidiabetic agents (not insulin)
- HbA1c 7.0 - 8.5% at last measurement (must be within 6 months of study)
- Most recent HbA1c within 1% of all measurements within preceding year
- Prepared to self-test blood glucose on a regular basis
- Prepared to use contraception during study if of child-bearing potential
Who cannot join
- Unstable cardiac disease (NYHA class III or IV heart failure, or unstable angina or myocardial infarction within last three months)
- Significant renal or hepatic impairment (creatinine>170 micromol/L, alanine transaminase or alkaline phosphatase > 3x upper limit of normal)
- Other medical condition or treatment likely to affect glycaemic control
- Previous history of significant hypoglycaemia
- Pregnancy
- Involvement in other clinical trial in last three months
- Known or suspected sensitivity to trial products
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Department, St John's Hospital
Livingston, Scotland, EH54 6PP
About this study
Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar levels in people with type 2 diabetes.
This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic acid for 12 weeks, or lipoic acid followed by placebo.
A blood test for overall diabetes control will be taken at the start and end of each 12 week period, and the change in control will be compared for lipoic acid vs placebo.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled crossover trial of lipoic acid for glycaemic control in type 2 diabetes.
The trial has 3 phases, each lasting 12 weeks. During phases 1 and 3, subjects take lipoic acid or placebo tablets, the order to be determined by randomization. Phase 2 is a 12-week washout period. The intervention is lipoic acid 200mg daily for 1 week, 400mg daily for the second week, and 600mg daily for weeks 3-12. Equivalent numbers of placebo tablets will be taken during the placebo phase.
The principal outcome measure is change in HbA1c between the start and end of lipoic acid supplementation, by comparison with the same change with placebo.
The secondary outcome measure is change in urine albumin:creatinine ratio over the same periods.
Assessments for safety will include standard adverse events reporting, repeated laboratory measurements throughout the study (blood count, renal and liver function) and hypoglycaemia frequency.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lipoic acid
- Keywords
- Type 2 diabetes mellitus, Glycaemic control, Lipoic acid, Diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic acidDrug
Lipoic acid capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Crossover - placebo then active Receives: Drug: Lipoic acid |
| 2 | Other | Crossover - active then placebo Receives: Drug: Lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change for lipoic acid vs placebo
Measured: 12 weeks
Secondary outcomes (1)
Urine ACR change for lipoic acid vs placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startDec 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- James D Walker, Principal investigator, NHS Lothian - St John's Hospital, Livingston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398892
- Sponsor's protocol ID
- 2005-001543-36
- Other IDs
- 2005
- Status last verified
- May 2024
- First submitted
- 13 Nov 2006
- Last updated
- 29 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00398892
- Acronym / sponsor ID
- 2005-001543-36
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Glycaemic control, Lipoic acid, Diabetic nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 14 Nov 2006 (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.
Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar levels in people with type 2 diabetes.
This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic acid for 12 weeks, or lipoic acid followed by placebo.
A blood test for overall diabetes control will be taken at the start and end of each 12 week period, and the change in control will be compared for lipoic acid vs placebo.
Detailed description
This is a randomized, double-blinded, placebo-controlled crossover trial of lipoic acid for glycaemic control in type 2 diabetes.
The trial has 3 phases, each lasting 12 weeks. During phases 1 and 3, subjects take lipoic acid or placebo tablets, the order to be determined by randomization. Phase 2 is a 12-week washout period. The intervention is lipoic acid 200mg daily for 1 week, 400mg daily for the second week, and 600mg daily for weeks 3-12. Equivalent numbers of placebo tablets will be taken during the placebo phase.
The principal outcome measure is change in HbA1c between the start and end of lipoic acid supplementation, by comparison with the same change with placebo.
The secondary outcome measure is change in urine albumin:creatinine ratio over the same periods.
Assessments for safety will include standard adverse events reporting, repeated laboratory measurements throughout the study (blood count, renal and liver function) and hypoglycaemia frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Lipoic acidCrossover - placebo then active |
| 2 | Other | Drug: Lipoic acidCrossover - active then placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- Age > 18 years
- Capable of giving informed consent
- Treated with oral antidiabetic agents (not insulin)
- HbA1c 7.0 - 8.5% at last measurement (must be within 6 months of study)
Key exclusion criteria (7 listed)
- Unstable cardiac disease (NYHA class III or IV heart failure, or unstable angina or myocardial infarction within last three months)
- Significant renal or hepatic impairment (creatinine>170 micromol/L, alanine transaminase or alkaline phosphatase > 3x upper limit of normal)
- Other medical condition or treatment likely to affect glycaemic control
- Previous history of significant hypoglycaemia
- Pregnancy
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 |
|---|---|---|
| Lipoic acidLipoic acid capsules | Drug | 1, 2 |
Primary outcome
HbA1c change for lipoic acid vs placebo
Time frame: 12 weeks
1 secondary outcome
Urine ACR change for lipoic acid vs placebo
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
James D Walker principal investigator
NHS Lothian - St John's Hospital, Livingston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipoic acid in people with Diabetes Mellitus, Type 2, run by University of Edinburgh at 1 site in United Kingdom.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 29 May 2024. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
HbA1c change for lipoic acid vs placebo (time frame: 12 weeks). 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 29 May 2024.