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Role of Pancreatic Triglyceride Content in Beta-cell Function

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00602953
First received: October 25, 2007
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Other: No intervention planned.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Role of Pancreatic Triglyceride Content in Beta-cell Function

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Association between panctreatic triglyceride and beta-cell function [ Time Frame: August/2012 ] [ Designated as safety issue: No ]
    To evaluate the association between pancreatic triglyceride (TG) content measured by the magnetic resonance spectroscopy (MRS) technique and beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).


Enrollment: 101
Study Start Date: September 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602953

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center
  More Information

No publications provided

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
Study First Received: October 25, 2007
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014