Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398892
Status:
WITHDRAWN
Last Update Posted:
2024-05-29
First Post:
2006-11-13
Brief Title:
The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 albumincreatinine 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
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 albumincreatinine 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None