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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

101

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.9 years study duration

Study Start

First participant enrolled

September 1, 2007

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed

3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed

5.4 years until next milestone

Results Posted

Study results publicly available

December 26, 2017

Completed

Last Updated

December 26, 2017

Status Verified

November 1, 2017

Enrollment Period

4.9 years

First QC Date

October 25, 2007

Results QC Date

August 17, 2017

Last Update Submit

November 29, 2017

Conditions

Obesity Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

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.