Role of Pancreatic Triglyceride Content in Beta-cell Function

Obesity Clinical Trial

Official title:

Role of Pancreatic Triglyceride Content in Beta-cell Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602953
• Other study ID #: 042007-021
• Secondary ID: 1K23RR02447001
• Status: Completed
• Phase: N/A
• First received: October 25, 2007
• Last updated: November 29, 2017
• Start date: September 2007
• Est. completion date: August 2012

Study information

• Verified date: November 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Other:
• No intervention planned.
This is a cross-sectional observational study, no intervention is planned.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Within 1 month after screening visit.
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.	At screening visit.
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.	At screening visit.
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 ß-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.