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

NCT ID: NCT00686972

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-10-31

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.

Conditions

Bariatric Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

GLP-1

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

Group Type: EXPERIMENTAL

GLP-1

Intervention Type: DRUG

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

Interventions

GLP-1

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

Intervention Type: DRUG

Other Intervention Names

Glucagon-like Peptide-1

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00004876

Identifier Type: -

Identifier Source: org_study_id