The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398892
Recruitment Status : Unknown
Verified October 2010 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : November 14, 2006
Last Update Posted : November 8, 2010
NHS Lothian
Information provided by:
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Lipoic acid Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Study Start Date : December 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Crossover - placebo then active
Drug: Lipoic acid
Lipoic acid capsules

Crossover - active then placebo
Drug: Lipoic acid
Lipoic acid capsules

Primary Outcome Measures :
  1. HbA1c change for lipoic acid vs placebo [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Urine ACR change for lipoic acid vs placebo [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398892

Contact: James D Walker, MD +44 1506 419666
Contact: Roderick E Warren +44 131 537 1752

United Kingdom
Diabetes Department, St John's Hospital Recruiting
Livingston, Scotland, United Kingdom, EH54 6PP
Principal Investigator: James D Walker, MD         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Principal Investigator: James D Walker NHS Lothian - St John's Hospital, Livingston

Responsible Party: Gemma Watson, The University of Edinburgh Identifier: NCT00398892     History of Changes
Other Study ID Numbers: 2005-001543-36
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: October 2010

Keywords provided by University of Edinburgh:
Type 2 diabetes mellitus
Glycaemic control
Lipoic acid
Diabetic nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances