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Role of Pancreatic Triglyceride Content in Beta-cell Function

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ClinicalTrials.gov Identifier: NCT00602953
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ildiko Lingvay, 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).

Condition or disease Intervention/treatment
Obesity Type 2 Diabetes Other: No intervention planned.

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Role of Pancreatic Triglyceride Content in Beta-cell Function
Study Start Date : September 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Pancreatic and Liver Fat [ Time Frame: 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).

  2. Beta-cell Function; AIRg - Acute Insulin Response to Glucose [ Time Frame: 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.


  3. Insulin Sensitivity (SI) [ Time Frame: 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.


  4. Disposition Index (DI) [ Time Frame: 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.



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602953


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center

Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00602953     History of Changes
Other Study ID Numbers: 042007-021
1K23RR02447001
First Posted: January 28, 2008    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: December 26, 2017
Last Verified: November 2017