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Changes in Ectopic Fat Following Surgically Induced Weight Loss

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ClinicalTrials.gov Identifier: NCT00840307
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : November 20, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

Brief Summary:
This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.

Condition or disease
Obesity Type 2 Diabetes

Detailed Description:

We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.

Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation

At each visit we do the following tests:

  1. MRS to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
  2. Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
  3. Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.

We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.


Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?
Study Start Date : August 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pancreatic and Liver Triglyceride (Fat) Content [ Time Frame: months after the first band inflation ]
    Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients already scheduled to undergo gastric banding within 1-2 months.

This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician

Criteria

Inclusion Criteria:

  • Greater than 18 years old
  • Fully understanding and willing to undergo study procedures
  • Available for follow-up
  • Understand and willing to sign informed consent
  • Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study

Exclusion Criteria:

  • Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
  • Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
  • History of pancreatic disease other than diabetes
  • Regular use of more than 2 alcoholic drinks per day
  • Pregnancy
  • Non-English speaking

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): NCT00840307


Locations
United States, Texas
University of Texas Southwestern
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 University of Texas Southwestern Medical Center

Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00840307     History of Changes
Other Study ID Numbers: 072008-039
NIH Grant: 1K23RR024470-01
First Posted: February 10, 2009    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

Keywords provided by Ildiko Lingvay, University of Texas Southwestern Medical Center:
Obesity
Type 2 Diabetes
Gastric Banding

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Weight Loss
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms