Effect of Long Term α-Lipoic Acid Treatment on Endothelial Function in Patients With Type 2 Diabetes

NCT00490867 | Completed Phase 2

• 1 other identifier: LipoicacidFBFV1.0
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the present study, endothelium dependent vasodilation will be induced by administration of acetylcholine (ACh). To ascertain whether the vascular effects, if any, of α-lipoic acid are limited to the endothelium, endothelium independent vasodilation will also be assessed by administration of glyceroltrinitrate (GTN). Study objectives To investigate the effect of α-lipoic acid therapy on endothelium dependent and independent vasodilation, assessed by forearm blood flow (FBF), in patients with type 2 diabetes mellitus Study design Randomized, double-blinded, parallel group study for 23 days: Day 1: FBF responses to acetylcholine and glyceroltrinitrate Day 2-22: intravenous infusion of 600 mg α-lipoic acid or placebo Day 23: FBF responses to acetylcholine and glyceroltrinitrate Study population 30 subjects with type 2 diabetes Study medication Acetylcholine (ACh) - intraarterial infusion, 25, 50, 100 nmol/min, infusion period 3 minutes/dose level Glyceroltrinitrate (GTN) - intraarterial infusion, 4, 8, 16 nmol/min, infusion period 3 minutes/dose level α-lipoic acid - intravenous infusion of 600 mg in 250 ml saline solution over 30 minutes Main outcome variables Forearm blood flow (Ratio between intervention and control arm) Additional outcome variables Arterial blood pressure, pulse rate, markers of inflammation and oxidative stress, Insulin plasma levels, Glucose plasma levels Risk/benefit assessment The insertion of intravenous cannula may cause mild and transient pain. A minor hematoma may occur at the site of cannula insertion. The insertion of the intraarterial cannula is performed under local anaesthesia and causes mild pain. The meassurement of forearm bloodflow, espacialy the wrist cuff (\>200 mmHG) may be uncomfortably. Local administration of drugs through a needle in the brachial artery allows the study of direct vascular effects of the drugs. Drug doses are 100 to 1000 times lower than a systemic effective dose, therefore no systemic adverse events are expected. There is experience in brachial artery infusions at our institution, and it is considered a safe technique. α-lipoic acid was well tolerated in healthy volunteers and subjects with diabetes at doses up to 600 mg intravenously and 1800 mg orally with side effects comparable with placebo. Altogether 50 ml blood will be collected throughout the study.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Forearm blood flow

  21 days

Interventions

Alpha lipoic acid DRUG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II diabetics; diagnosed on a clinical basis: positive family history; age of manifestation \> 40 years; BMI \>25; initial therapy without insulin
• Age: 40 - 65 years
• Body mass index between 26 and 35 \[Wascher 1998\]
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Treatment with concomitent therapy, including vasoactive drugs, is allowed during the study. Will not be changed during the study

You may not qualify if:

• Participation in a clinical trial in the 3 weeks preceeding the study
• History or signs of macrovascular disease
• History of hypertensitivity to the trial drug or to drugs with a similar chemical structure
• Changes in concomitant therapy during the study

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Wolzt, MD

  Clinical Pharmacology - Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 25, 2007
• Study Start: July 1, 2004
• Study Completion: August 1, 2007
• Last Updated: March 20, 2018

Record last verified: 2007-06