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

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00686972
• Other study ID #: NA_00004876
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: March 25, 2010
• Start date: May 2007
• Est. completion date: May 2012

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: May 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Drug:
• GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion		2 years	No