Obesity, Type 2 Diabetes
Conditions
Keywords
Obesity, Type 2 Diabetes, Gastric Banding
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.
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.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient With Gastric Band 20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Patient With Gastric Band |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 49.1 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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).
Time frame: months after the first band inflation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patient With Gastric Band | Pancreatic and Liver Triglyceride (Fat) Content | Pancreatic fat | 6.44 percent |
| Patient With Gastric Band | Pancreatic and Liver Triglyceride (Fat) Content | Liver fat | 2.08 percent |