Obesity, Type 2 Diabetes
Conditions
Brief summary
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).
Interventions
OTHERNo intervention planned.
This is a cross-sectional observational study, no intervention is planned.
Sponsors
National Institutes of Health (NIH)
University of Texas Southwestern Medical Center
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* adults without prior history of pancreatic disease (other than diabetes)
Exclusion criteria
* use of unapproved medications * contraindications to the MRI procedure * contraindications to frequent blood draws * pregnancy * use of more than 2 alcoholic drinks/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic and Liver Fat | Within 1 month after screening visit. | 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). |
| Beta-cell Function; AIRg - Acute Insulin Response to Glucose | At screening visit. | 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. |
| Insulin Sensitivity (SI) | At screening visit. | 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. |
| Disposition Index (DI) | At screening visit. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Normal weight and normal glucose tolerance.
No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 15 |
| Pre-diabetes Impaired fasting glucose of impaired glucose tolerance.
No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 26 |
| 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. | 47 |
| Type 2 Diabetes Patients with type 2 diabetes.
No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 13 |
| Type 1 Diabetes Patients with type 1 diabetes.
No intervention planned.: This is a cross-sectional observational study, no intervention is planned. | 0 |
| Total | 101 |
Baseline characteristics
| Characteristic | Pre-diabetes | Overweight | Healthy Volunteers | Type 2 Diabetes | Type 1 Diabetes | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 47 Participants | 15 Participants | 13 Participants | 0 Participants | 101 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 10 | 39 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 8 | 47 years STANDARD_DEVIATION 9 | — | 40 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 26 Participants | 47 Participants | 15 Participants | 13 Participants | — | 101 Participants |
| Sex: Female, Male Female | 15 Participants | 35 Participants | 11 Participants | 10 Participants | 0 Participants | 71 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 4 Participants | 3 Participants | 0 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 26 | 0 / 47 | 0 / 13 | 0 / 0 |
| other Total, other adverse events | 0 / 15 | 0 / 26 | 0 / 47 | 0 / 13 | 0 / 0 |
| serious Total, serious adverse events | 0 / 15 | 0 / 26 | 0 / 47 | 0 / 13 | 0 / 0 |
Outcome results
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.
Time frame: At screening visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers | Beta-cell Function; AIRg - Acute Insulin Response to Glucose | 197.55 microU/mL x min |
| Pre-diabetes | Beta-cell Function; AIRg - Acute Insulin Response to Glucose | 321.09 microU/mL x min |
| Overweight | Beta-cell Function; AIRg - Acute Insulin Response to Glucose | 519.33 microU/mL x min |
| Type 2 Diabetes | Beta-cell Function; AIRg - Acute Insulin Response to Glucose | 8.9 microU/mL x min |
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.
Time frame: At screening visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers | Disposition Index (DI) | 1001.8 Number |
| Pre-diabetes | Disposition Index (DI) | 739.84 Number |
| Overweight | Disposition Index (DI) | 1031.26 Number |
| Type 2 Diabetes | Disposition Index (DI) | 15.61 Number |
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.
Time frame: At screening visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers | Insulin Sensitivity (SI) | 5.48 min-1 per pU/mL x 10v4 |
| Pre-diabetes | Insulin Sensitivity (SI) | 2.28 min-1 per pU/mL x 10v4 |
| Overweight | Insulin Sensitivity (SI) | 2.29 min-1 per pU/mL x 10v4 |
| Type 2 Diabetes | Insulin Sensitivity (SI) | 1.55 min-1 per pU/mL x 10v4 |
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).
Time frame: Within 1 month after screening visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Volunteers | Pancreatic and Liver Fat | Pancreatic fat MRS | 1.87 percent |
| Healthy Volunteers | Pancreatic and Liver Fat | Liver fat MRS | 0.96 percent |
| Pre-diabetes | Pancreatic and Liver Fat | Liver fat MRS | 4.09 percent |
| Pre-diabetes | Pancreatic and Liver Fat | Pancreatic fat MRS | 6.57 percent |
| Overweight | Pancreatic and Liver Fat | Pancreatic fat MRS | 3.61 percent |
| Overweight | Pancreatic and Liver Fat | Liver fat MRS | 3.33 percent |
| Type 2 Diabetes | Pancreatic and Liver Fat | Pancreatic fat MRS | 5.85 percent |
| Type 2 Diabetes | Pancreatic and Liver Fat | Liver fat MRS | 8.76 percent |