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| ID | Type | Description | Link |
|---|---|---|---|
| pending | Other Grant/Funding Number | pending |
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We are interested in how skeletal muscle processes fat and how this may affect insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. We know that if pharmaceutical grade fat is infused into people, they develop insulin resistance. Likewise, we would like to infuse pharmaceutical grade fat into trained subjects, believing that trained subjects will have 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 fat infusion without the fat component.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lipid trained | Experimental | 20% lipid infusion in trained subjects |
|
| glycerol trained | Active Comparator | glycerol infusion into trained subjects |
|
| lipid untrained | Experimental | lipid infusion into untrained subjects |
|
| glycerol untrained | Active Comparator | glycerol infusion into untrained subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20% lipid infusion | Drug | 1.5 ml/min for 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion | Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion) | at 6 hours after starting lipid/glycerol infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa S Chow, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22639293 | Derived | Chow LS, Seaquist ER, Eberly LE, Mashek MT, Schimke JM, Nair KS, Mashek DG. Acute free fatty acid elevation eliminates endurance training effect on insulin sensitivity. J Clin Endocrinol Metab. 2012 Aug;97(8):2890-7. doi: 10.1210/jc.2012-1515. Epub 2012 May 25. |
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we had anticipated enrollment of 36 subjects but ended up finishing the study with 33 subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Lipid Trained | 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
| FG001 | Glycerol Trained | glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
| FG002 | Lipid Untrained | lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
| FG003 | Glycerol Untrained | glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lipid Trained | 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
| BG001 | Glycerol Trained | glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion | Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion) | Posted | Mean | Standard Deviation | M value | at 6 hours after starting lipid/glycerol infusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lipid Trained | 20% lipid infusion in trained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| numbness | Musculoskeletal and connective tissue disorders | MedRA | Non-systematic Assessment | slight skin numbness at site of muscle biopsy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Chow | University of Minnesota | 612-625-8934 | chow0007@umn.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| glycerol | Drug | glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
|
|
| BG002 | Lipid Untrained | lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
| BG003 | Glycerol Untrained | glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| insulin sensitivity | Mean | Standard Deviation | M value |
|
| OG002 | Lipid Untrained | lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours |
| OG003 | Glycerol Untrained | glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Glycerol Trained | glycerol infusion into trained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, | 0 | 7 | 1 | 7 |
| EG002 | Lipid Untrained | lipid infusion into untrained subjects 20% lipid infusion: 1.5 ml/min for 6 hours | 0 | 9 | 0 | 9 |
| EG003 | Glycerol Untrained | glycerol infusion into untrained subjects glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min, | 0 | 7 | 0 | 6 |
|
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| D004700 | Endocrine System Diseases |
| D002241 |
| Carbohydrates |