Changes in Ectopic Fat Following Surgically Induced Weight Loss

NCT00840307 | Completed Results

• 2 other identifiers: 072008-039NIH Grant: 1K23RR024470-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes

Keywords

Obesity; Type 2 Diabetes; Gastric Banding

Outcome Measures

Primary Outcomes (1)

• Pancreatic and Liver Triglyceride (Fat) Content

  Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).

  months after the first band inflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Ildiko Lingvay
• Organization: UT Southwestern Medical Center

ildiko.lingvay@utsouthwestern.edu

214-648-2779

Study Officials

• Ildiko Lingvay, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, MSCS

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: August 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 13, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11

Locations

US (1)