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

Primary Purpose

Bariatric Surgery

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GLP-1

About this trial

This is an interventional other trial for Bariatric Surgery focused on measuring Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GLP-1

Arm Description

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

Outcomes

Primary Outcome Measures

Insulin Secretion

Secondary Outcome Measures

Full Information

NCT ID

NCT00686972

First Posted

May 27, 2008

Last Updated

June 1, 2017

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT00686972

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

PI left JHU

Study Start Date

May 2007 (Actual)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bariatric Surgery

Keywords

Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLP-1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GLP-1

Other Intervention Name(s)

Glucagon-like Peptide-1

Intervention Description

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

Primary Outcome Measure Information:

Title

Insulin Secretion

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dariush Elahi, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

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

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