Status:
WITHDRAWN
The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00398892
Start Date
December 1 2009
End Date
January 1 2011
Last Update
May 29 2024
Active Locations (1)
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1
Diabetes Department, St John's Hospital
Livingston, Scotland, United Kingdom, EH54 6PP