An observational study in Obesity and Type 2 Diabetes, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by University of Texas Southwestern Medical Center · Observational
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).
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 101 is below the median of 132 across 1,338 observational studies indexed under Obesity.
Browse Obesity studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Normal weight and normal glucose tolerance.
Other: No intervention planned.
Impaired fasting glucose of impaired glucose tolerance.
Other: No intervention planned.
Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.
Other: No intervention planned.
Patients with type 2 diabetes.
Other: No intervention planned.
Patients with type 1 diabetes.
Other: No intervention planned.
This is a cross-sectional observational study, no intervention is planned.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At screening visit.
| Milestone | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes |
|---|---|---|---|---|---|
| Started | 15 | 26 | 47 | 13 | 0 |
| Completed | 15 | 26 | 47 | 13 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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).
| percent | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes |
|---|---|---|---|---|---|
| Pancreatic fat MRS | 1.87 (0.2 to 6.26) | 6.57 (1.90 to 17.93) | 3.61 (0.79 to 8.98) | 5.85 (3.43 to 13.96) | — |
| Liver fat MRS | 0.96 (0.61 to 1.83) | 4.09 (1.86 to 12.43) | 3.33 (1.29 to 6.99) | 8.76 (4.93 to 21.18) | — |
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.
| microU/mL x min | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes |
|---|---|---|---|---|---|
| Beta-cell Function; AIRg - Acute Insulin Response to Glucose | 197.55 (118.15 to 237.42) | 321.09 (151.71 to 446.46) | 519.33 (385.59 to 927.69) | 8.9 (1.0 to 56.58) | — |
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.
| min-1 per pU/mL x 10v4 | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes |
|---|---|---|---|---|---|
| Insulin Sensitivity (SI) | 5.48 (3.85 to 7.46) | 2.28 (1.6 to 4.55) | 2.29 (1.54 to 2.84) | 1.55 (1.28 to 3.76) | — |
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.
| Number | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes |
|---|---|---|---|---|---|
| Disposition Index (DI) | 1001.8 (744.52 to 1332.1) | 739.84 (478.15 to 1026.53) | 1031.26 (749.6 to 1796.35) | 15.61 (4.31 to 133.19) | — |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Volunteers | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Pre-diabetes | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Overweight | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Type 2 Diabetes | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Type 1 Diabetes | — | — | — |
| Age, Categorical(Participants) | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 26 | 47 | 13 | 0 | 101 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes | Total |
|---|---|---|---|---|---|---|
| Mean | 31 ± 8 | 41 ± 10 | 39 ± 9 | 47 ± 9 | — | 40 ± 10 |
| Sex: Female, Male(Participants) | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes | Total |
|---|---|---|---|---|---|---|
| Female | 11 | 15 | 35 | 10 | 0 | 71 |
| Male | 4 | 11 | 12 | 3 | 0 | 30 |
| Region of Enrollment(Participants) | Healthy Volunteers | Pre-diabetes | Overweight | Type 2 Diabetes | Type 1 Diabetes | Total |
|---|---|---|---|---|---|---|
| United States | 15 | 26 | 47 | 13 | — | 101 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center →