Clinical trial NCT00398892: The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Official title: The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
Glycaemic control
Lipoic acid
Diabetic nephropathy
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2006-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: HbA1c change for lipoic acid vs placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Urine ACR change for lipoic acid vs placebo
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Livingston
country: United Kingdom
facility: Diabetes Department, St John's Hospital
state: Scotland
Study officials:
affiliation: NHS Lothian - St John's Hospital, Livingston
name: James D Walker
role: PRINCIPAL_INVESTIGATOR
References: