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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK071142 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Studies of myocardial fuel selection using a novel palmitate-based PET probe
A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Experimental | Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). |
|
| Insulin Clamp | Experimental | Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thiapalmitate tracer | Drug | Radiolabeled tracer infusion; occurs in all treatment arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Fatty Acid Uptake Rate | PET measure of fatty acid uptake rate | 4 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Oxidation Rate | PET measure of total oxidation rate | 4 Hours |
| Myocardial Perfusion Rate | PET measure of total myocardial perfusion (blood flow) |
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Inclusion Criteria:
Lean:
Type 2 diabetes mellitus:
Exclusion Criteria:
Lean:
*Use of any chronic medications
Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Kieren J Mather, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital GCRC | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26732686 | Result | Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lean Control | Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days. thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms Saline: Saline infusion for control |
| FG001 | Type 2 DM | Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days. thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control (Saline) Infusion (*Day 1) |
| |||||||||||||
| Insulin Infusion (*Day 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lean Controls | Lean non-diabetic control participants, taking no regular medications. |
| BG001 | Type 2 Diabetes | Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists. |
| 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 | Myocardial Fatty Acid Uptake Rate | PET measure of fatty acid uptake rate | Posted | Mean | Standard Error | umol/min/100g | 4 Hours |
|
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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 | Saline | Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms Saline: Saline infusion for control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kieren J Mather | Indiana University | 317-278-7826 | kmather@iu.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Saline infusion for control |
|
| Insulin | Drug | Insulin infusion for insulin/glucose clamp procedure |
|
| 4 Hours |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Type 2 DM - Saline | Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms |
| OG003 | Type 2 DM - Insulin Clamp | Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms |
|
|
| Secondary | Myocardial Oxidation Rate | PET measure of total oxidation rate | Posted | Mean | Standard Error | ml/min/100g | 4 Hours |
|
|
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| Secondary | Myocardial Perfusion Rate | PET measure of total myocardial perfusion (blood flow) | Posted | Mean | Standard Error | ml/min/100g | 4 Hours |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Insulin Clamp | Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms Insulin: Insulin infusion for insulin/glucose clamp procedure | 0 | 18 | 0 | 18 |
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| D004700 | Endocrine System Diseases |
| D017670 |
| Sodium Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |