- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00686972
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
June 1, 2017 updated by: Johns Hopkins University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
|
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin Secretion
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 27, 2008
First Posted (Estimate)
May 30, 2008
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00004876
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bariatric Surgery
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruitingGERD | Bariatric Surgery Candidate | Revisional Bariatric SurgeryVenezuela
-
Universidad de ZaragozaCentro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas... and other collaboratorsRecruitingBariatric Surgery | Bariatric Surgery and Whole Body Vibration TrainingSpain
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
University of Illinois at Urbana-ChampaignCarle Foundation HospitalRecruitingBariatric Surgery Candidate | Bariatric Surgical ProcedureUnited States
-
McMaster UniversityNot yet recruitingRobotic Surgery | Bariatric Surgery
-
Western Galilee Hospital-NahariyaCompletedBariatric Patients Undergoing Bariatric SurgeryIsrael
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruiting
-
The University of Texas Health Science Center,...Recruiting
-
Centre Hospitalier Intercommunal CreteilRecruitingBariatric SurgeryFrance
-
Yale-NUS CollegeCompleted
Clinical Trials on GLP-1
-
Zealand PharmaProfil Institut für Stoffwechselforschung GmbHRecruitingSafety and TolerabilityGermany
-
University of CopenhagenGentofte Hospital, DenmarkRecruiting
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; Merck Sharp & Dohme LLCCompletedHyperglycemiaGermany
-
Zealand PharmaCompleted
-
University Hospital TuebingenMerck Sharp & Dohme LLCWithdrawn
-
Indiana UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHealthy | Type 2 Diabetes MellitusUnited States
-
University of Mississippi Medical CenterRecruitingDiabetes Mellitus, Type 2 | Osteoporosis, PostmenopausalUnited States
-
Mayo ClinicMerck Sharp & Dohme LLCCompleted
-
University of ChicagoCompleted
-
Papworth Hospital NHS Foundation TrustCompletedAngina, Stable | Type2 Diabetes | Coronary Stenosis