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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00686972
First received: May 27, 2008
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Bariatric Surgery
Drug: GLP-1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dariush Elahi, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00686972     History of Changes
Other Study ID Numbers: NA_00004876
Study First Received: May 27, 2008
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014