Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00686972Other idNA_00004876

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI left JHU

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 51 participants (actual)
Sponsor: Johns Hopkins University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: May 2007
Primary completion: Oct 2010
Completion: Oct 2010
First posted: 30 May 2008 (estimated)
Last update posted: 2 Jul 2017
Conditions: Bariatric Surgery

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph 2
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
NCT00686972
May 2007 to Oct 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GLP-1Drug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Secretion
Time frame · 2 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 2 years

Insulin Secretion

Group	Value
GLP-1	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GLP-15 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.	0 / 0	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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