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The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

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ClinicalTrials.gov Identifier: NCT00686972
Recruitment Status : Terminated (PI left JHU)
First Posted : May 30, 2008
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Drug: GLP-1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Actual Study Start Date : May 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
 Drug: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Other Name: Glucagon-like Peptide-1


Outcome Measures
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Primary Outcome Measures :
  1. Insulin Secretion [ Time Frame: 2 years ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686972


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00686972     History of Changes
Other Study ID Numbers: NA_00004876
First Posted: May 30, 2008    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
Bariatric Surgery
Glucose Regulation
Cardiac Function
Body Composition

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Glucagon-Like Peptide 1
Glucagon
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents