The Effect of A-lipoic Acid (ALA) on Fatty Acid-induced Impairment of Glucose-stimulated Insulin Secretion

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronically elevated free fatty acids impair insulin sensitivity and insulin secretion (ie lipotoxicity) by a combination of oxidative stress, endoplasmic reticulum (ER) stress and inflammation. This study will test whether alpha-lipoic acid, which has potent antioxidant and anti-inflammatory properties, prevents or ameliorates lipotoxicity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Canadian Diabetes Association
• Treatments: Insulin; Insulin, Globin Zinc; Thioctic Acid

Criteria

Inclusion Criteria:

Men and women aged 20-65 years:

1. Written informed consent obtained

2. Body mass index (BMI) > 27kg/m2

3. Glucose tolerance test may be normal or demonstrate impaired glucose tolerance but not frank diabetes

4. Hemoglobin above 130g/L

Exclusion Criteria:

1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years

2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy

3. Type 2 diabetes by history or OGTT

4. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure

5. Any laboratory values: AST > 2x ULN; ALT > 2x ULN; TSH > 6 mU/l

6. A history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions. History of hypersensitivity to heparin

7. Current addiction to alcohol or substances of abuse as determined by the investigator

8. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation

9. Any lipid lowering of hypoglycemic agents

10. Previous history of asthma

11. Will not donate blood three months prior to and three months post study procedures

12. Thrombocytopenia