Role of Pancreatic Triglyceride Content in Beta-cell Function

University of Texas Southwestern Medical Center101 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Obesity Type 2 Diabetes

Interventions

No intervention planned.OTHER

This is a cross-sectional observational study, no intervention is planned.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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