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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23RR02447001 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The study evaluates if fat accumulates in the pancreas in individuals at risk of developing obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict the residual functional capacity of the pancreas (insulin secretion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Normal weight and normal glucose tolerance. |
| |
| Pre-diabetes | Impaired fasting glucose of impaired glucose tolerance. |
| |
| Overweight | Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. |
| |
| Type 2 diabetes | Patients with type 2 diabetes. |
| |
| Type 1 diabetes | Patients with type 1 diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention planned. | Other | This is a cross-sectional observational study, no intervention is planned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic and Liver Fat | Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI). | Within 1 month after screening visit. |
| Beta-cell Function; AIRg - Acute Insulin Response to Glucose | Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. | At screening visit. |
| Insulin Sensitivity (SI) | Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin. | At screening visit. |
| Disposition Index (DI) | Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function. |
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Inclusion Criteria:
Exclusion Criteria:
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We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.
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| Name | Affiliation | Role |
|---|---|---|
| Ildiko Lingvay, MD, MPH, MSCS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| FG001 | Pre-diabetes | Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| FG002 | Overweight | Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| FG003 | Type 2 Diabetes | Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| FG004 | Type 1 Diabetes | Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| BG001 | Pre-diabetes |
| 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 | Pancreatic and Liver Fat | Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI). | Posted | Median | Inter-Quartile Range | percent | Within 1 month after screening visit. |
|
2 weeks
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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 | Healthy Volunteers | Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. ILDIKO LINGVAY | UT Southwestern Medical Center, Dallas, TX | 214-648-2779 | ildiko.lingvay@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| At screening visit. |
Impaired fasting glucose of impaired glucose tolerance.
No intervention planned.: This is a cross-sectional observational study, no intervention is planned.
| BG002 | Overweight | Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| BG003 | Type 2 Diabetes | Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| BG004 | Type 1 Diabetes | Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Overweight | Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| OG003 | Type 2 Diabetes | Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
| OG004 | Type 1 Diabetes | Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. |
|
|
| Primary | Beta-cell Function; AIRg - Acute Insulin Response to Glucose | Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. | Posted | Median | Inter-Quartile Range | microU/mL x min | At screening visit. |
|
|
|
| Primary | Insulin Sensitivity (SI) | Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin. | Posted | Median | Inter-Quartile Range | min-1 per pU/mL x 10v4 | At screening visit. |
|
|
|
| Primary | Disposition Index (DI) | Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function. | Posted | Median | Inter-Quartile Range | Number | At screening visit. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Pre-diabetes | Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Overweight | Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG003 | Type 2 Diabetes | Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG004 | Type 1 Diabetes | Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |