Changes in Ectopic Fat Following Surgically Induced Weight Loss

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Type 2 Diabetes

Keywords

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Obesity Type 2 Diabetes Gastric Banding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ildiko Lingvay

MD, MPH, MSCS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ildiko Lingvay, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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University of Texas Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NIH Grant: 1K23RR024470-01

Identifier Type: -

Identifier Source: secondary_id

072008-039