Trial Outcomes & Findings for Role of Pancreatic Triglyceride Content in Beta-cell Function (NCT NCT00602953)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

Within 1 month after screening visit.

Results posted on

2017-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Volunteers Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Pre-diabetes Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	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.	Type 2 Diabetes Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.
Overall Study STARTED	15	26	47	13
Overall Study COMPLETED	15	26	47	13
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Pancreatic Triglyceride Content in Beta-cell Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=15 Participants Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Pre-diabetes n=26 Participants Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Overweight n=47 Participants 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.	Type 2 Diabetes n=13 Participants Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Type 1 Diabetes Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants	13 Participants n=4 Participants	0 Participants n=21 Participants	101 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	31 years STANDARD_DEVIATION 8 • n=5 Participants	41 years STANDARD_DEVIATION 10 • n=7 Participants	39 years STANDARD_DEVIATION 9 • n=5 Participants	47 years STANDARD_DEVIATION 9 • n=4 Participants	—	40 years STANDARD_DEVIATION 10 • n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	71 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	30 Participants n=8 Participants
Region of Enrollment United States	15 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants	13 Participants n=4 Participants	—	101 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=15 Participants Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Pre-diabetes n=26 Participants Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Overweight n=47 Participants 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.	Type 2 Diabetes n=13 Participants Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Type 1 Diabetes Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.
Pancreatic and Liver Fat Liver fat MRS	0.96 percent Interval 0.61 to 1.83	4.09 percent Interval 1.86 to 12.43	3.33 percent Interval 1.29 to 6.99	8.76 percent Interval 4.93 to 21.18	—
Pancreatic and Liver Fat Pancreatic fat MRS	1.87 percent Interval 0.2 to 6.26	6.57 percent Interval 1.9 to 17.93	3.61 percent Interval 0.79 to 8.98	5.85 percent Interval 3.43 to 13.96	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=15 Participants Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Pre-diabetes n=26 Participants Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Overweight n=47 Participants 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.	Type 2 Diabetes n=13 Participants Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Type 1 Diabetes Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.
Beta-cell Function; AIRg - Acute Insulin Response to Glucose	197.55 microU/mL x min Interval 118.15 to 237.42	321.09 microU/mL x min Interval 151.71 to 446.46	519.33 microU/mL x min Interval 385.59 to 927.69	8.9 microU/mL x min Interval 1.0 to 56.58	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=15 Participants Normal weight and normal glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Pre-diabetes n=26 Participants Impaired fasting glucose of impaired glucose tolerance. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Overweight n=47 Participants 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.	Type 2 Diabetes n=13 Participants Patients with type 2 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.	Type 1 Diabetes Patients with type 1 diabetes. No intervention planned.: This is a cross-sectional observational study, no intervention is planned.
Insulin Sensitivity (SI)	5.48 min-1 per pU/mL x 10v4 Interval 3.85 to 7.46	2.28 min-1 per pU/mL x 10v4 Interval 1.6 to 4.55	2.29 min-1 per pU/mL x 10v4 Interval 1.54 to 2.84	1.55 min-1 per pU/mL x 10v4 Interval 1.28 to 3.76	—

PRIMARY outcome

Timeframe: 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.