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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Lipoic acid

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes mellitus, Glycaemic control, Lipoic acid, Diabetic nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Diabetes Department, St John's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

Crossover - placebo then active

Crossover - active then placebo

Outcomes

Primary Outcome Measures

HbA1c change for lipoic acid vs placebo

Secondary Outcome Measures

Urine ACR change for lipoic acid vs placebo

Full Information

NCT ID

NCT00398892

First Posted

November 13, 2006

Last Updated

November 5, 2010

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

1. Study Identification

Unique Protocol Identification Number

NCT00398892

Brief Title

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

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Edinburgh

Collaborators

NHS Lothian

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus, Glycaemic control, Lipoic acid, Diabetic nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Crossover - placebo then active

Arm Title

Arm Type

Other

Arm Description

Crossover - active then placebo

Intervention Type

Drug

Intervention Name(s)

Lipoic acid

Intervention Description

Lipoic acid capsules

Primary Outcome Measure Information:

Title

HbA1c change for lipoic acid vs placebo

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Urine ACR change for lipoic acid vs placebo

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James D Walker, MD

Phone

+44 1506 419666

james.walker@wlt.scot.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Roderick E Warren

Phone

+44 131 537 1752

roderick.warren@luht.scot.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D Walker

Organizational Affiliation

NHS Lothian - St John's Hospital, Livingston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Department, St John's Hospital

City

Livingston

State/Province

Scotland

ZIP/Postal Code

EH54 6PP

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James D Walker, MD

12. IPD Sharing Statement

Learn more about this trial

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

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