Changes in Ectopic Fat Following Surgically Induced Weight Loss

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00840307
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 20
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

• 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: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. Pancreatic and Liver Triglyceride (Fat) Content [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT00840307
• Other Study ID Numbers: 072008-039; NIH Grant: 1K23RR024470-01
• First Posted: Feb 10, 2009
• Last Update Posted: Dec 13, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center: Obesity; Type 2 Diabetes; Gastric Banding
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Patient With Gastric Band
Arm/Group Description	20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Patient With Gastric Band
Arm/Group Description	20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.1 (11.0)
Sex: Female, Male (Count of Participants)
Female	17 85%
Male	3 15%
Region of Enrollment (Count of Participants)
United States	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient With Gastric Band
Arm/Group Description	20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
Measure Participants	16
Pancreatic fat	6.44
Liver fat	2.08

Adverse Events

Time Frame	13 months
Arm/Group Title	Patient With Gastric Band
Arm/Group Description	20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
All Cause Mortality
	Patient With Gastric Band
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Patient With Gastric Band
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Patient With Gastric Band
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.