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PI left JHU
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 | Experimental | 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 | Drug | 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dariush Elahi, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucagon Like Peptide 1 -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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Secretion | 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. | Posted | 2 years |
|
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The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Adverse Event data, if collected, is unknown since no data are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins University Clinical Trials Program | Johns Hopkins University School of Medicine | 410-550-6484 | registerclinicaltrials@jhmi.edu |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |