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

NCT00398892 | Withdrawn Phase 2

• 1 other identifier: 2005-001543-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HbA1c change for lipoic acid vs placebo

  12 weeks

Secondary Outcomes (1)

• Urine ACR change for lipoic acid vs placebo

  12 weeks

Study Arms (2)

1

OTHER

Crossover - placebo then active

Drug: Lipoic acid

2

OTHER

Crossover - active then placebo

Drug: Lipoic acid

Interventions

Lipoic acid DRUG

Lipoic acid capsules

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Diabetes Department, St John's Hospital

Livingston, Scotland, EH54 6PP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• James D Walker

  NHS Lothian - St John's Hospital, Livingston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

GB (1)