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

November 5, 2010 updated by: University of Edinburgh

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Scotland
      • Livingston, Scotland, United Kingdom, EH54 6PP
        • Recruiting
        • Diabetes Department, St John's Hospital
        • Principal Investigator:
          • James D Walker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Crossover - placebo then active
Drug: Lipoic acid
Lipoic acid capsules
Other: 2
Crossover - active then placebo
Drug: Lipoic acid
Lipoic acid capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change for lipoic acid vs placebo
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Urine ACR change for lipoic acid vs placebo
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: James D Walker, NHS Lothian - St John's Hospital, Livingston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

November 7, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-001543-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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