The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Primary Purpose
Bariatric Surgery
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLP-1
Sponsored by
About this trial
This is an interventional other trial for Bariatric Surgery focused on measuring Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GLP-1
Arm Description
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Outcomes
Primary Outcome Measures
Insulin Secretion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00686972
Brief Title
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Official Title
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left JHU
Study Start Date
May 2007 (Actual)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery
Keywords
Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-1
Arm Type
Experimental
Arm Description
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Intervention Type
Drug
Intervention Name(s)
GLP-1
Other Intervention Name(s)
Glucagon-like Peptide-1
Intervention Description
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Primary Outcome Measure Information:
Title
Insulin Secretion
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariush Elahi, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
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