Lipid Metabolism Disorders Clinical Trial
— LIDDIAOfficial title:
The Dual Role of Intramyocellular Lipids in Mediating Insulin Resistance: Assessing the Mechanisms of the Athlete's Paradox
NCT number | NCT03314714 |
Other study ID # | DDZ-LIDDIA01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2017 |
Est. completion date | June 1, 2023 |
Verified date | June 2023 |
Source | German Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Accumulation of intramyocellular lipids (IMCLs) due to increased supply of fatty acids can induce defects in the insulin signaling cascade, causing skeletal muscle insulin resistance. However, the causes for muscle insulin resistance are not well understood. The association of elevated IMCLs and insulin resistance has been shown in obese humans and individuals with type 2 diabetes as well as several animal models of insulin resistance. Despite the strong relationship between IMCLs and insulin resistance, this suggested relationship disappears when well-trained endurance athletes are included into this consideration as this group is highly insulin sensitive. This metabolic enigma has been termed the 'athlete's paradox'. The aim of this project is to resolve the mechanisms contributing to the athlete's paradox.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility | Inclusion criteria - Insulin-resistant, non-athletic persons with a comparable content of IMCLs as the athletes - Healthy, insulin-sensitive, normal-weight, non-athletic (BMI 18-25 kg / m2) individuals - Endurance trained individuals (VO2max=60 mL / kg / min ? and 45 mL / kg / min ?) - Male and female, age between = 18 and = 69 years Exclusion criteria - Acute infections / fever - Immunosuppressive therapy - Serious heart, kidney or liver disease: - New York Heart Association-Classification (NYHA) stage = II - creatinine = 1.6 mg / dl - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = two-fold upper reference value - severe peripheral artery disease (PAD) (stage IV) - autoimmune diseases - Anemia (Hb <12g / l) - Severe psychiatric illness or addiction - Malignant cancer - Participation in another intervention study - Blood clotting disorders or increased risk of thrombosis - Pregnancy, lactation - Cigarettes (or non-smokers <1 year) - alcohol consumption (men> 30g / d, women> 20g / d) - ECG changes (ST reductions or - elevations, high-grade rhythm disorders (salvage or polytope extrasystoles, ventricular tachycardia) - Heart diseases (angina pectoris at rest or under light load, myocardial infarction, thromboembolic processes / pulmonary embolism or severe arteriosclerosis, acute myocarditis or pericarditis, cardiac wall aneurysms, cor pulmonale, aortic stenosis) - Hypertension (> 220/120 mmHg) - Pacemaker - Metallic and magnetic implants (for example, mechanical heart valves, joint prostheses, clip after vascular surgery, middle and inner ear implants or fresh dental implants, penis implants) - Waist circumference> 135cm - Claustrophobia |
Country | Name | City | State |
---|---|---|---|
Germany | German Diabetes Center | Düsseldorf | NRW |
Netherlands | Maastricht University | Maastricht |
Lead Sponsor | Collaborator |
---|---|
German Diabetes Center | Maastricht University |
Germany, Netherlands,
Goodpaster BH, He J, Watkins S, Kelley DE. Skeletal muscle lipid content and insulin resistance: evidence for a paradox in endurance-trained athletes. J Clin Endocrinol Metab. 2001 Dec;86(12):5755-61. doi: 10.1210/jcem.86.12.8075. — View Citation
Roden M, Price TB, Perseghin G, Petersen KF, Rothman DL, Cline GW, Shulman GI. Mechanism of free fatty acid-induced insulin resistance in humans. J Clin Invest. 1996 Jun 15;97(12):2859-65. doi: 10.1172/JCI118742. — View Citation
Szendroedi J, Yoshimura T, Phielix E, Koliaki C, Marcucci M, Zhang D, Jelenik T, Muller J, Herder C, Nowotny P, Shulman GI, Roden M. Role of diacylglycerol activation of PKCtheta in lipid-induced muscle insulin resistance in humans. Proc Natl Acad Sci U S A. 2014 Jul 1;111(26):9597-602. doi: 10.1073/pnas.1409229111. Epub 2014 Jun 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of intramyocellular lipid content via magnetic resonance spectroscopy | Intramyocellular lipid content assessed via magnetic resonance spectroscopy (%lipid) in endurance-trained athletes and sedentary individuals | 2 years | |
Primary | Assessment of intramyocellular lipid composition via mass spectrometry | Detailed composition of intramyocellular lipids assessed via mass spectrometry (concentration of bioactive lipids) in endurance-trained athletes and sedentary individuals | 2 years |
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