Role of Pancreatic Triglyceride Content in Beta-cell Function

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 Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Other: No intervention planned.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Normal weight and normal glucose tolerance.	Other: No intervention planned.; This is a cross-sectional observational study, no intervention is planned.
Pre-diabetes; Impaired fasting glucose of impaired glucose tolerance.	Other: 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.	Other: No intervention planned.; This is a cross-sectional observational study, no intervention is planned.
Type 2 diabetes; Patients with type 2 diabetes.	Other: No intervention planned.; This is a cross-sectional observational study, no intervention is planned.
Type 1 diabetes; Patients with type 1 diabetes.	Other: No intervention planned.; This is a cross-sectional observational study, no intervention is planned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	At screening visit.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 25, 2007
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 042007-021; 1K23RR02447001