Role of Pancreatic Triglyceride Content in Beta-cell Function

Completed

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Other: No intervention planned.

• Registration Number: NCT00602953
• Lead Sponsor: University of Texas Southwestern Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-28
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2017-08-17
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Results First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-diabetes	No intervention planned.	Impaired fasting glucose of impaired glucose tolerance.
Overweight	No intervention planned.	Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.
Healthy volunteers	No intervention planned.	Normal weight and normal glucose tolerance.
Type 2 diabetes	No intervention planned.	Patients with type 2 diabetes.
Type 1 diabetes	No intervention planned.	Patients with type 1 diabetes.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States