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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00398892
First received: November 13, 2006
Last updated: November 5, 2010
Last verified: October 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • HbA1c change for lipoic acid vs placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine ACR change for lipoic acid vs placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Crossover - placebo then active
Drug: Lipoic acid
Lipoic acid capsules
2
Crossover - active then placebo
Drug: Lipoic acid
Lipoic acid capsules

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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Gemma Watson, The University of Edinburgh
ClinicalTrials.gov Identifier: NCT00398892     History of Changes
Other Study ID Numbers: 2005-001543-36
Study First Received: November 13, 2006
Last Updated: November 5, 2010
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

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

ClinicalTrials.gov processed this record on August 26, 2014