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- Essai clinique NCT00786487
Training Effects on Skeletal Muscle Fatty Acid Metabolism
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
We are interested in how skeletal muscle processes fat and its effect on insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. We know that if pharmaceutical grade lipid is infused into people, they develop insulin resistance. Thus, we would like to infuse pharmaceutical grade lipid into trained subjects, believing that trained subjects will develop less insulin resistance, less decline in muscle energy function, and less accumulation of fat metabolites than untrained subjects. For comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the same as pharmaceutical grade lipid infusion without the lipid component.
Three visits will be required. The first visit will involve measurement of fitness. A second visit will involve measurement of insulin resistance. The third visit will involve an inpatient stay, with a six hour infusion either the lipid or glycerol. Three muscle biopsies (before, during and after) will be take in conjunction with the infusion.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
- We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
- The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
- The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).
Exclusion Criteria:
- Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
- The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
- If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
- If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
- Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
- Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: lipid trained
20% lipid infusion in trained subjects
|
1.5 ml/min for 6 hours
Autres noms:
|
Comparateur actif: glycerol trained
glycerol infusion into trained subjects
|
glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Autres noms:
|
Expérimental: lipid untrained
lipid infusion into untrained subjects
|
1.5 ml/min for 6 hours
Autres noms:
|
Comparateur actif: glycerol untrained
glycerol infusion into untrained subjects
|
glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion
Délai: at 6 hours after starting lipid/glycerol infusion
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Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)
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at 6 hours after starting lipid/glycerol infusion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lisa S Chow, MD, University of Minnesota
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0804M29862
- Pending (Autre identifiant: Ceim HCSC (ERB of Hospital Clinico San Carlos)))
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