NCT00686972

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3.4 years

First QC Date

May 27, 2008

Results QC Date

May 1, 2017

Last Update Submit

June 1, 2017

Conditions

Bariatric Surgery

Keywords

Bariatric SurgeryGlucose RegulationCardiac FunctionBody Composition

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

    2 years

Study Arms (1)

GLP-1

EXPERIMENTAL

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

Drug: GLP-1

Interventions

GLP-1DRUG

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

Also known as: Glucagon-like Peptide-1
GLP-1

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Volunteers whose hematocrit level does not meet the above criteria.
  • Pregnant and or lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Johns Hopkins University Clinical Trials Program
Organization
Johns Hopkins University School of Medicine
registerclinicaltrials@jhmi.edu
410-550-6484

Study Officials

  • Dariush Elahi, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

May 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 2, 2017

Results First Posted

July 2, 2017

Record last verified: 2017-06

Locations

US(1)