Bariatric Surgery
Conditions
Keywords
Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition
Brief summary
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.
Detailed description
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.
Interventions
DRUGGLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female volunteers 21-65 years. * BMI \> 40. * Preoperative hematocrit level of at least 34% for women and 38% for men. * Postoperative hematocrit level of at least 34% for women and 36% for men.
Exclusion criteria
* Volunteers whose hematocrit level does not meet the above criteria. * Pregnant and or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Secretion | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLP-1 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | P.I, Left institution. Study terminated | 51 |
Baseline characteristics
| Characteristic | GLP-1 |
|---|---|
| Age, Customized >=21 and <=65 | 51 participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Insulin Secretion
Time frame: 2 years
Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.