The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	University of Edinburgh NHS Lothian
Information provided by:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT00398892

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Lipoic acid	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Thioctic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:

HbA1c change for lipoic acid vs placebo

Secondary Outcome Measures:

Urine ACR change for lipoic acid vs placebo

Estimated Enrollment:	18
Study Start Date:	December 2006

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398892

Contacts

Contact: James D Walker, MD	+44 1506 419666	james.walker@wlt.scot.nhs.uk
Contact: Roderick E Warren	+44 131 537 1752	roderick.warren@luht.scot.nhs.uk

Locations

United Kingdom, Scotland
Diabetes Department, St John's Hospital
Livingston, Scotland, United Kingdom, EH54 6PP

Sponsors and Collaborators

University of Edinburgh

NHS Lothian

Investigators

Principal Investigator:

James D Walker

NHS Lothian - St John's Hospital, Livingston

More Information

Study ID Numbers:	2005-001543-36
Study First Received:	November 13, 2006
Last Updated:	December 18, 2006
ClinicalTrials.gov Identifier:	NCT00398892
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:

Type 2 diabetes mellitus
Glycaemic control
Lipoic acid
Diabetic nephropathy

Study placed in the following topic categories:

Metabolic Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Thioctic Acid

Additional relevant MeSH terms:

Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009